{"recall":{"id":"fda-device-99344","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Aniara Diagnostica LLC recalls 3 products","firm":"Aniara Diagnostica LLC","date":"2026-07-01","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905","code":"UDI-DI: 05070002420378, Lot Number: KE132603","quantity":"4 units","number":"Z-2894-2026","classification":"Class II"},{"name":"5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905","code":"UDI-DI: 05070002420392, Lot Number: KE132601","quantity":"7 units","number":"Z-2895-2026","classification":"Class II"},{"name":"5-PLASMA Bivalirudin Control, Model Number 5D-44905","code":"UDI-DI: 05070002420385, Lot Number: KE132602","quantity":"9 units","number":"Z-2896-2026","classification":"Class II"}],"reason":"Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of IL, NC, TN.","nationwide":true,"states":[],"units":"4 units; 7 units; 9 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=99344","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"035de3a4f18c9db4","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=99344","record":[{"status":"Ongoing","city":"West Chester","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99344","recalling_firm":"Aniara Diagnostica LLC","address_1":"7768 Service Center Dr","address_2":"","postal_code":"45069-2442","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IL, NC, TN.","recall_number":"Z-2894-2026","product_description":"5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905","product_quantity":"4 units","reason_for_recall":"Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.","recall_initiation_date":"20260701","center_classification_date":"20260805","report_date":"20260812","code_info":"UDI-DI: 05070002420378, Lot Number: KE132603","more_code_info":""},{"status":"Ongoing","city":"West Chester","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99344","recalling_firm":"Aniara Diagnostica LLC","address_1":"7768 Service Center Dr","address_2":"","postal_code":"45069-2442","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IL, NC, TN.","recall_number":"Z-2895-2026","product_description":"5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905","product_quantity":"7 units","reason_for_recall":"Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.","recall_initiation_date":"20260701","center_classification_date":"20260805","report_date":"20260812","code_info":"UDI-DI: 05070002420392, Lot Number: KE132601","more_code_info":""},{"status":"Ongoing","city":"West Chester","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99344","recalling_firm":"Aniara Diagnostica LLC","address_1":"7768 Service Center Dr","address_2":"","postal_code":"45069-2442","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IL, NC, TN.","recall_number":"Z-2896-2026","product_description":"5-PLASMA Bivalirudin Control, Model Number 5D-44905","product_quantity":"9 units","reason_for_recall":"Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.","recall_initiation_date":"20260701","center_classification_date":"20260805","report_date":"20260812","code_info":"UDI-DI: 05070002420385, Lot Number: KE132602","more_code_info":""}]}}