Abbott recalls Alinity c Hemoglobin Reagent Kit (REF: 08P4320) due to potential false high A1c results. Affected units include specific lots and model numbers. 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 may produce false high A1c results. This could lead to incorrect diabetes management decisions if used in medical testing.
The reagent kit may generate falsely elevated A1c levels, which can lead to incorrect diabetes management decisions. This happens due to a potential issue with the reagent's accuracy in the testing process.
People using the Alinity c Hemoglobin Reagent Kit for diabetes testing may be affected. Those with diabetes who rely on A1c test results are at higher risk.
Check for the model number REF: 08P4320 on the kit. Affected lots include 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01.
Look for the model number REF: 08P4320 and affected lots on the reagent kit.
Reach out to Abbott Laboratories for specific instructions on how to handle the kit.
The recall is due to a potential for falsely elevated A1c results, which could lead to incorrect diabetes management decisions.
Affected model numbers include REF: 08P4320 with specific lots: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01.
No immediate stop is required; the recall is for potential false results, not an immediate safety hazard.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1455-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1455-2022 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.
