Ortho-Clinical Diagnostics recalls VITROS Vitamin B1:2 Reagent Packs (Catalog 1453489) due to potential calibration failures affecting vitamin B12 test accuracy. Affected lots 2601, 2610, 2620.
The reagent pack exhibits the potential for an increased frequency of calibration failures.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs (Catalog 1453489) because they may cause calibration failures in blood tests. This could lead to inaccurate vitamin B12 measurements, which might affect anemia diagnosis.
The reagent packs may cause calibration failures in the VITROS 3600, 5600, or ECi/ECiQ systems. This could result in inaccurate vitamin B12 test results, potentially leading to incorrect anemia diagnoses.
Users of VITROS Vitamin B12 Reagent Packs with lot numbers 2601, 2610, or 2620 are affected. Laboratory staff and healthcare providers who use these reagents for blood tests are most at risk.
Check the lot number on the reagent pack. Affected lots are 2601, 2610, and 2620. The product is used in VITROS Immunodiagnostic Systems for vitamin B12 testing.
Look for the lot number on the reagent pack; affected lots are 2601, 2610, and 2620.
The reagent pack may cause calibration failures in VITROS systems, leading to inaccurate vitamin B12 test results.
Check the lot number; if it's 2601, 2610, or 2620, contact Ortho-Clinical Diagnostics for instructions.
No, the hazard is limited to potential calibration failures affecting test accuracy, not physical harm.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0392-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0392-2019 from Ortho-Clinical Diagnostics. 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.
