{"recall":{"id":"fda-device-99546","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":true,"kind":"device","title":"Nova Biomedical Corporation recalls 5 products","firm":"Nova Biomedical Corporation","date":"2026-07-29","reported":"2026-09-23","status":"Ongoing","classification":"Class I","products":[{"name":"StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.","code":"Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","quantity":"20,616 units","number":"Z-3128-2026","classification":"Class I"},{"name":"StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.","code":"Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","quantity":"10,941 units","number":"Z-3129-2026","classification":"Class I"},{"name":"StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.","code":"Model No: 63683. UDI-DI: 00385480636834. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","quantity":"1,858 units","number":"Z-3130-2026","classification":"Class I"},{"name":"StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.","code":"Model No: 63910. UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","quantity":"8,939 units","number":"Z-3131-2026","classification":"Class I"},{"name":"StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.","code":"Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","quantity":"2,044 units","number":"Z-3132-2026","classification":"Class I"}],"reason":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","nationwide":true,"states":[],"units":"20,616 units; 10,941 units; 1,858 units; 8,939 units; 2,044 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99546","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fefc01c31be2d09b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99546","record":[{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99546","recalling_firm":"Nova Biomedical Corporation","address_1":"200 Prospect St","address_2":"N/A","postal_code":"02453-3407","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","recall_number":"Z-3128-2026","product_description":"StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.","product_quantity":"20,616 units","reason_for_recall":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode   including patient identification (ID) barcodes and quality control (QC) solution ID barcodes   when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","recall_initiation_date":"20260729","center_classification_date":"20260911","report_date":"20260923","code_info":"Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99546","recalling_firm":"Nova Biomedical Corporation","address_1":"200 Prospect St","address_2":"N/A","postal_code":"02453-3407","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","recall_number":"Z-3129-2026","product_description":"StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.","product_quantity":"10,941 units","reason_for_recall":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode   including patient identification (ID) barcodes and quality control (QC) solution ID barcodes   when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","recall_initiation_date":"20260729","center_classification_date":"20260911","report_date":"20260923","code_info":"Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99546","recalling_firm":"Nova Biomedical Corporation","address_1":"200 Prospect St","address_2":"N/A","postal_code":"02453-3407","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","recall_number":"Z-3130-2026","product_description":"StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.","product_quantity":"1,858 units","reason_for_recall":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode   including patient identification (ID) barcodes and quality control (QC) solution ID barcodes   when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","recall_initiation_date":"20260729","center_classification_date":"20260911","report_date":"20260923","code_info":"Model No: 63683.  UDI-DI: 00385480636834. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99546","recalling_firm":"Nova Biomedical Corporation","address_1":"200 Prospect St","address_2":"N/A","postal_code":"02453-3407","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","recall_number":"Z-3131-2026","product_description":"StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.","product_quantity":"8,939 units","reason_for_recall":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode   including patient identification (ID) barcodes and quality control (QC) solution ID barcodes   when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","recall_initiation_date":"20260729","center_classification_date":"20260911","report_date":"20260923","code_info":"Model No: 63910.   UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99546","recalling_firm":"Nova Biomedical Corporation","address_1":"200 Prospect St","address_2":"N/A","postal_code":"02453-3407","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.","recall_number":"Z-3132-2026","product_description":"StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.","product_quantity":"2,044 units","reason_for_recall":"A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode   including patient identification (ID) barcodes and quality control (QC) solution ID barcodes   when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.","recall_initiation_date":"20260729","center_classification_date":"20260911","report_date":"20260923","code_info":"Model No: 66429.  UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.","more_code_info":""}]}}