Abbott recalls specific Alinity c A-ALT reagent kits due to potential for 15% under-recovery on high samples and >10% result shifts with bilirubin over 31 mg/dL, risking incorrect patient results.
There is a potential for 15% 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 Alinity c Activated Alanine Aminotransferase reagent kits because they may produce inaccurate test results for patients with high bilirubin levels or very high sample values. This could lead to incorrect diagnoses or treatment decisions.
The reagent kits may under-recover samples greater than 1,200 U/L by up to 15% and shift patient results by more than 10% when bilirubin concentrations exceed 31 mg/dL. This could cause inaccurate test results, potentially leading to incorrect medical decisions.
Patients using the recalled Alinity c A-ALT reagent kits for blood tests may be affected, particularly those with elevated bilirubin levels or very high sample values. Healthcare providers using these kits are most at risk of incorrect results.
Check for the lot numbers and expiration dates listed: 83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022.
Review the lot number and expiration date on the kit to see if it matches the recalled items listed in the notice.
The recall is due to potential for 15% under-recovery on samples greater than 1,200 U/L and a >10% shift in results for samples with bilirubin over 31 mg/dL, which could lead to incorrect patient results.
The official notice does not specify a remedy, so contact Abbott Laboratories for guidance on next steps.
Check the lot number and expiration date against the listed numbers: 83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2184-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2184-2021 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.
