Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Control products with elevated sample results risk. Affected units may show inaccurate test results; contact for remedy.
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control products that may show elevated results when used with certain calibrators. This could lead to inaccurate test results for SARS-CoV-2 antibody testing.
The control product may show elevated signal values when used with eight lots of the calibrator, and decreased signal in one lot. This can cause inaccurate test results for SARS-CoV-2 antibody testing.
Users of VITROS immunodiagnostic systems for SARS-CoV-2 antibody testing may be affected. Those using the specific lot numbers listed in the recall are most at risk.
Check for product code 6199921 (10758750033355) and lot number 0110 with expiration date 25-NOV-20. The product is used in monitoring VITROS immunodiagnostic systems for SARS-CoV-2 antibody tests.
Verify your product code and lot number against the recall information provided.
The VITROS Anti-SARS-CoV-2 IgG Control product code 6199921 (10758750033355) with lot number 0110 and expiration date 25-NOV-20.
The control product may show elevated signal values when used with eight lots of the calibrator and decreased signal in one lot, leading to inaccurate test results.
The recall record does not specify a remedy, so contact Ortho Clinical Diagnostics for further instructions.
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-0451-2021 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0451-2021 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.
