{"recall":{"id":"fda-device-99843","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Instrumentation Laboratory recalls 2 products","firm":"Instrumentation Laboratory","date":"2026-09-03","reported":"2026-10-21","status":"Ongoing","classification":"Class I","products":[{"name":"HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic","code":"Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).","quantity":"434 units","number":"Z-0001-2027","classification":"Class I"},{"name":"HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)","code":"Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).","quantity":"1,414 units","number":"Z-0002-2027","classification":"Class I"}],"reason":"Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.","nationwide":true,"states":[],"units":"434 units; 1,414 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=99843","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"842ec923bda0e83b","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=99843","record":[{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99843","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.","recall_number":"Z-0001-2027","product_description":"HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic","product_quantity":"434 units","reason_for_recall":"Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.","recall_initiation_date":"20260903","center_classification_date":"20261009","report_date":"20261021","code_info":"Part Number: 0009800127.  UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).","more_code_info":""},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99843","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.","recall_number":"Z-0002-2027","product_description":"HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)","product_quantity":"1,414 units","reason_for_recall":"Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.","recall_initiation_date":"20260903","center_classification_date":"20261009","report_date":"20261021","code_info":"Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).","more_code_info":""}]}}