Z-2186-2021Class II

REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01)...

Name: Z-2186-2021 REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01)...
Creator: Abbott Laboratories
Published: 2021-06-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-06-10 / Open, Classified

FDA source

Abbott Laboratories began a recall of REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866 on 2021-06-10. FDA classified it as Class II and gives the reason as "There is a potential for >10% 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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2186-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-10
Posted: 2021-08-02
Recalling firm: Abbott Medical
Product: REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Product code: CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Reason for recall: There is a potential for >10% 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
FDA 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 listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 5. Please retain this letter for your laboratory records. 6.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. 7. 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 FDA0178).
Quantity in commerce: 36 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, 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.
Product codes and lots: Lot Numbers / Expiration Date 15014UN20 20OCT2021 09153UN21 09MAR2022 *Not distributed within the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2186-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2184-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2185-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2186-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2187-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02

Product code CKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)