Abbott recalls specific Activated Alanine Aminotransferase test kits for potential incorrect patient results due to under-recovery in high sample concentrations. Affected lots may cause inaccurate bilirubin results.
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 could produce incorrect patient results for samples with high bilirubin levels or very high enzyme concentrations. This might lead to wrong medical decisions if not addressed.
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 inaccurate medical decisions if not corrected.
Healthcare professionals using Abbott Activated Alanine Aminotransferase test kits for laboratory testing. Patients receiving results from these kits may be at risk of incorrect diagnoses.
Check the lot number on the kit, which includes codes like 84126UN20, 03676UN20, 10597UN20, 26275UN20, 77748UN20, 65958UN20, or 81824UN21. These kits were sold with specific expiration dates between July 2021 and February 2022.
Look for lot numbers such as 84126UN20, 03676UN20, 10597UN20, 26275UN20, 77748UN20, 65958UN20, or 81824UN21 on the test kit packaging.
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.
Affected lots include 84126UN20 (expiring 09JUL2021), 03676UN20 (25AUG2021), 10597UN20 (29AUG2021), 26275UN20 (20OCT2021), 77748UN20 (08DEC2021), 65958UN20 (08DEC2021), and 81824UN21 (16FEB2022).
No remedy is specified in the recall notice, so users should check the lot number and contact Abbott if they have affected kits.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2187-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2187-2021 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.
