Ortho-Clinical recalls SARS-CoV-2 IgG Quantitative Reagent Packs due to incorrect on-analyzer stability time in instructions. This affects lab use on VITROS systems. No action needed per recall.
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Ortho-Clinical is recalling SARS-CoV-2 IgG reagent packs used in lab testing because the instructions incorrectly state the reagent stays stable for 8 weeks on the analyzer when it should be 6 weeks. This means labs might get inaccurate test results if they use the reagent beyond its actual stability period.
The reagent's on-analyzer stability (OAS) time is listed as 8 weeks in the instructions, but it actually degrades after 6 weeks. This could lead to inaccurate test results if the reagent is used beyond its actual stability period.
Labs using Ortho-Clinical's SARS-CoV-2 IgG reagent packs on VITROS ECi/ECiQ/3600 or 5600/XT 7600 systems. Lab technicians and healthcare facilities that handle these tests are most at risk.
Check for product code 6199960 or UDI-DI 10758750034413 on the reagent pack. The reagent is intended for use on VITROS ECi/ECiQ/3600 or 5600/XT 7600 systems. All lots, including expired and future releases, are affected.
Look for product code 6199960 or UDI-DI 10758750034413 on the reagent pack.
No action is required per the recall notice.
The reagent should be stable for 6 weeks on the analyzer, not 8 weeks as stated in the instructions.
This reagent is intended for use on VITROS ECi/ECiQ/3600 and 5600/XT 7600 Integrated Systems.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1367-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1367-2022 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.
