{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "187940", "product_res_number": "Z-2184-2021", "event_date_initiated": "2021-06-10", "event_date_created": "2021-08-02", "recall_status": "Open, Classified", "res_event_number": "88123", "product_code": "CKA", "product_description": "REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569", "code_info": "Lot Numbers / Expiration Date  83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022", "firm_fei_number": "3016438761", "recalling_firm": "Abbott Laboratories", "address_1": "1915 Hurd Dr", "city": "Irving", "state": "TX", "postal_code": "75038", "additional_info_contact": "Dana Dominguez Schmidt\n224-667-8598", "reason_for_recall": "There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.", "root_cause_description": "Under Investigation by firm", "action": "On June 10, 2021, Abbott issued a Product Correction letter to US consignees via FedEx. In addition to informing consignees about the recall, Abbott asked customers to take the following actions: \n\n1. Immediately install AALT assay file, version 10, obtained from www.corelaboratory.abbott\n\n2. Manually configure the HighLinearity assay parameter to 1,200 U/L. For detailed information, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2.\n\n3 Complete and return the Customer Reply Form.\n\n4. If you have forwarded the products listed above to other laboratories, please inform them of\nthis Product Correction and provide to them a copy of this letter.\n\n5. Please retain this letter for your laboratory records.\n\n6.If you or any of the health care providers you serve have questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.\n\n7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (18003321088), or by fax (1800\nFDA0178).", "product_quantity": "4,727 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of VA, UT, TX, TN, SD,PA, NY, ME, ID, CA and the countries of AFGHANISTAN, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVI, CANADA, CAYMAN ISLANDS, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FAROE ISLAND, FINLAND, FRANCE, GERMANY, GREENLAND, Hong Kong, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, MONTENEGRO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL, PR CHINA, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UNITED KINGDOM, VIETNAM.", "openfda": { "k_number": [ "K820525", "K821048", "K800689", "K897163", "K771152", "K120945", "K973869", "K922884", "K952427", "K791083", "K890698", "K770882", "K861658", "K875079", "K913846", "K901702", "K761269", "K780636", "K811694", "K872483", "K770314", "K020487", "K780102", "K844251", "K780040", "K791641", "K843111", "K874586", "K974003", "K864335", "K810355", "K930070", "K113382", "K870879", "K921016", "K924245", "K903198", "K941497", "K821882", "K800038", "K770991", "K772030", "K935180", "K961123", "K842241", "K842564", "K061020", "K891469", "K923510", "K914464", "K952744", "K781726", "K863962", "K860727", "K840705", "K871782", "K841060", "K944080", "K780791", "K790522", "K821805", "K863053", "K980028", "K860110", "K830959", "K885144", "K901105", "K884936", "K872830", "K896001", "K780373", "K862833", "K941287", "K874835", "K923623", "K821206", "K800115", "K941314", "K896234", "K821946", "K922109", "K880275", "K790016", "K812591", "K771466", "K861792", "K821536", "K843334", "K820394", "K893752", "K832639", "K905767", "K760194", "K851995", "K813495", "K812926", "K923257", "K951818", "K900905", "K780462", "K883205", "K864850", "K864906", "K801857", "K851923", "K971323", "K870086", "K863253", "K965134", "K822494", "K854502", "K771033", "K883181", "K884376", "K893560", "K861002", "K861366", "K892930", "K791084", "K862209", "K861231", "K852867", "K801119", "K925339", "K951332", "K920335", "K854186" ], "registration_number": [ "1827821", "2050010", "1000403749", "3005333358", "2030861", "3014325803", "1220972", "3021841051", "1319681", "1616487", "2939693", "3010825766", "8020316", "1832216", "3013660430", "2250051", "8040374", "1181121", "3003741796", "1319809", "1319436", "2050012", "3011989923", "3016438761", "3006716639", "2247288", "2517506", "3005360469", "3008517993", "3005094123", "2432235", "3003795116", "3002809144", "3000148879", "9610529", "1063851", "3006198300", "3018771894", "3007662974", "9680746", "2085064", "3004493545", "3048199746", "3003593973", "9610126" ], "fei_number": [ "3005670738", "1827821", "2050010", "3002806809", "1000403749", "3005333358", "1000120319", "3014325803", "1220972", "1000305840", "3002806559", "3021841051", "1000206808", "1000135102", "1616487", "2939693", "3010825766", "5864", "1832216", "3013660430", "2250051", "1181121", "3003741796", "1000136573", "2050012", "3011989923", "3016438761", "3006716639", "1000122044", "2517506", "3008517993", "3005094123", "2432235", "3003795116", "3002809144", "3000215862", "3000148879", "3006198300", "1000442352", "3018771894", "3007662974", "3002806560", "3004493545", "3048199746", "3003593973" ], "device_name": "Nadh Oxidation/Nad Reduction, Alt/Sgpt", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1030", "device_class": "1" } } ] }