Abbott recalls Alinity c Hemoglobin Reagent Kit (REF: 08P4377) due to potential false high A1c results. Affected units include specific lot numbers and sizes. Consumers should contact Abbott for details.
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Abbott is recalling Alinity c Hemoglobin Reagent Kits that could produce false high A1c results. This may lead to incorrect diabetes management decisions if used in blood tests.
The reagent kit can generate falsely elevated A1c results when used with Abbott's ARCHITECT or Alinity c hemoglobin A1c assays. This could lead to incorrect diabetes management decisions if the false high results are acted on.
People using the Alinity c Hemoglobin Reagent Kit for blood tests may be affected. Those with diabetes who rely on A1c test results are at higher risk.
Check for the reagent kit with lot numbers 59801UQ04 or 60763UQ09. The kit includes specific sizes: R1 (5 x 46.0 mL), R2 (5 x 18.3 mL), and A1cDL (5 x 67.6 mL).
Reach out to Abbott Laboratories for specific instructions on how to handle the recalled kit.
The recalled kit is the Alinity c Hemoglobin Reagent Kit (REF: 08P4377) with lot numbers 59801UQ04 and 60763UQ09.
The reagent kit can produce falsely elevated A1c results when used with Abbott's ARCHITECT or Alinity c hemoglobin A1c assays.
Look for the lot numbers 59801UQ04 or 60763UQ09 on the kit's packaging, which includes specific sizes: R1 (5 x 46.0 mL), R2 (5 x 18.3 mL), and A1cDL (5 x 67.6 mL).
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1456-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1456-2022 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.
