Ortho Clinical Diagnostics recalls VITROS SARS-CoV-2 IgG Calibrator due to potential elevated test results. This in-vitro diagnostic product may cause inaccurate results in specific lots. Affected labs should check product codes and lot numbers.
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 specific lots of their VITROS SARS-CoV-2 IgG Calibrator for in-vitro diagnostic use. The recall is due to potential elevated test results in eight lots and decreased signal in one lot, which could lead to inaccurate COVID-19 test results.
The calibrator may produce elevated signal/cutoff values in eight specific lots and decreased signal in one lot. This can cause inaccurate test results for SARS-CoV-2 IgG, potentially leading to incorrect identification of recent or prior infection.
Labs using the VITROS SARS-CoV-2 IgG Calibrator for in-vitro diagnostics are affected. Laboratories that purchased the product with specific lot numbers are most at risk.
Check the product code (6199920) and lot numbers (0165 to 0230) on the VITROS SARS-CoV-2 IgG Calibrator. The product was sold with specific expiration dates from November 2020 to December 2020.
Verify the product code (6199920) and lot numbers (0165 to 0230) on the calibrator to confirm if it is affected.
The calibrator may produce elevated signal/cutoff values in eight lots and decreased signal in one lot, causing inaccurate SARS-CoV-2 IgG test results.
Labs that purchased the VITROS SARS-CoV-2 IgG Calibrator with lot numbers 0165 to 0230 from November 2020 to December 2020.
Check the product code and lot numbers to confirm if it is affected; no specific action is required beyond verification as the recall does not include a remedy.
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-0450-2021 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0450-2021 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.
