Abbott recalls specific Activated Alanine Aminotransferase test kits for potential incorrect patient results due to under-recovery in high-concentration samples. Affected units include lot numbers 02954UN20 through 81823UN21.
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 certain Activated Alanine Aminotransferase test kits that may produce inaccurate patient results for samples with high bilirubin or enzyme levels. This could lead to incorrect medical diagnoses if used without the recall fix.
The test kits may under-recover samples with enzyme levels over 1,200 U/L or bilirubin levels above 31 mg/dL, causing a >10% shift in patient results. This could lead to incorrect medical diagnoses if the kits are used without correction.
Healthcare providers using Abbott Activated Alanine Aminotransferase test kits with specific lot numbers are affected. Patients receiving tests using these kits may face incorrect results if the kits are not recalled.
Check the lot number on the kit label, which includes numbers like 02954UN20, 37921UN20, or 81823UN21. These kits were sold with expiration dates from August 2021 through February 2022.
Look for lot numbers on the kit label such as 02954UN20, 37921UN20, or 81823UN21.
The test kit may produce inaccurate results for samples with high bilirubin or enzyme levels, potentially leading to incorrect patient diagnoses.
Check the lot number on the kit label. If it matches the affected numbers, contact Abbott for guidance on next steps.
The recall is for potential incorrect results, not direct patient harm. However, incorrect diagnoses could occur if the test is used without correction.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2185-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2185-2021 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.
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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.
