Recall Z-2186-2021

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-determined cause: Under Investigation by firm

Action taken

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).