Ortho Clinical Diagnostics recalls VITROS SARS-CoV-2 IgG Quantitative Controls that may give delayed test results if used outside expected control range. Affected lots expired by Nov 2021.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
Ortho Clinical Diagnostics is recalling VITROS SARS-CoV-2 IgG Quantitative Controls that may give delayed test results if used outside the expected control range. This affects lab tests for monitoring SARS-CoV-2 antibody levels. The recall is due to potential for inaccurate test results.
These controls may give delayed test results if used outside the expected control range. This means lab tests for SARS-CoV-2 antibodies could be inaccurate, potentially leading to incorrect conclusions about infection status.
Lab users who have the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls with product code 6199966 and lot number 0040 (expired by Nov 2021) are affected. Most at risk are laboratory technicians using these controls for SARS-CoV-2 antibody testing.
Check for product code 6199966 and lot number 0040 on the control vials. The expiration date is November 19, 2021. These controls are used with specific VITROS lab systems for SARS-CoV-2 antibody testing.
Verify the product code (6199966) and lot number (0040) on the control vials.
The VITROS SARS-CoV-2 IgG Quantitative Controls may give delayed test results if used outside the expected control range, leading to inaccurate test results.
Check the product code and lot number. If it matches 6199966 and lot 0040, contact Ortho Clinical Diagnostics for guidance.
The product is safe to use if within the expected control range. Using it outside this range may cause delayed results.
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-0120-2022 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0120-2022 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.
