Ortho-Clinical recalls VITROS HbA1c Reagent Kits due to potential for both positive and negative HbA1c results, which could lead to misdiagnosis of diabetes. Affected lots listed in the recall notice.
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Ortho-Clinical is recalling VITROS HbA1c Reagent Kits that could produce inaccurate blood sugar test results, leading to misdiagnosis of diabetes. This affects labs using specific lots of the reagent kits.
The reagent kits may produce both unexpected positive and negative results for HbA1c, which can lead to misdiagnosis of diabetes. This happens due to a potential issue with the chemical reaction in the test.
Labs using the VITROS HbA1c Reagent Kits with the listed lot numbers are affected. Patients relying on these kits for diabetes diagnosis may be at risk of incorrect results.
Check the lot numbers on the reagent kit packaging: 29-9396, 29-9466, 30-9647, 30-9803, 31-9648, 32-9925, 33-1097, 33-1105, 33-1228, or 34-1345. These lots were sold between September 2023 and October 2024.
Look for the lot numbers listed in the recall notice on the reagent kit packaging.
The reagent kits may produce both unexpected positive and negative HbA1c results, which could lead to misdiagnosis of diabetes.
Affected lot numbers include 29-9396, 29-9466, 30-9647, 30-9803, 31-9648, 32-9925, 33-1097, 33-1105, 33-1228, and 34-1345.
The recall does not require immediate stop use; labs should check the lot numbers and contact Ortho-Clinical if needed.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1628-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1628-2023 from Ortho-Clinical. 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.
