Abbott recalls Activated Alanine Aminotransferase (A-ALT) devices for potential incorrect patient results due to under-recovery in high-concentration samples. Affected units include specific lot numbers with expiration dates.
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
Abbott is recalling Activated Alanine Aminotransferase (A-ALT) test devices that may produce inaccurate results for patients with high bilirubin levels or very high enzyme concentrations. This could lead to incorrect medical diagnoses if used without the recall fix.
The device may under-recover samples with enzyme concentrations over 1,200 U/L, causing results to be too low. It can also shift patient results by more than 10% when bilirubin levels exceed 31 mg/dL, potentially leading to incorrect diagnoses.
Healthcare providers using Abbott Activated Alanine Aminotransferase devices for laboratory testing are likely affected. Patients with high bilirubin levels or very high enzyme concentrations may be at risk of incorrect test results.
Check for lot numbers 15014UN21 (expiration 20OCT2021) or 09153UN21 (expiration 09MAR2022) on the device packaging. These units are not distributed within the US.
Look for lot numbers 15014UN21 (expires 20OCT2021) or 09153UN21 (expires 09MAR2022) on the device packaging.
The device may produce inaccurate results for specific patient samples, but it is not unsafe to use if the recall remedy is followed.
Check for lot numbers 15014UN21 (expires 20OCT2021) or 09153UN21 (expires 09MAR2022) on the device packaging.
The recall does not specify a remedy, so contact Abbott Laboratories for guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2186-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2186-2021 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
