Recall Z-2184-2021 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Abbott Laboratories
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
| Date | Jun 10, 2021 |
| Status | Open, Classified |
| Reason | 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 | 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: 1. Immediately install AALT assay file, version 10, obtained from www.corelaboratory.abbott 2. 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. 3 Complete and return the Customer Reply Form. 4. If you have forwarded the products |
| Quantity | 4,727 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.