Abbott Laboratories REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers / Expiration Date 84126UN20 / 09JUL2021 03676UN20 / 25AUG2021 10597UN20 / 29AUG2021 26275UN20 / 20OCT2021 77748UN20 / 08DEC2021 65958UN20 / 08DEC2021 81824UN21 / 16FEB2022
Abbott Laboratories is recalling REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 0 due to 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 pote. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026