Ortho-Clinical recalls VITROS SARS-CoV-2 antibody calibrators with incorrect calibrator levels that may delay patient test results. Affected products include specific data release versions and lot numbers.
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
Ortho-Clinical is recalling VITROS SARS-CoV-2 antibody calibrators that have incorrect calibrator levels set in the assay data disks. This can cause delayed patient test results if used without correction.
The assay data disks (ADD) for these calibrators have two calibrator levels set incorrectly. This error can cause patient test results to be delayed because the system may not process the samples properly.
Healthcare facilities using the recalled VITROS calibrators for SARS-CoV-2 antibody testing may be affected. Laboratory staff and patients using these products could experience delayed test results.
Check for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators with data release versions 6213 through 6218. Products with lot numbers 0230 (exp 22-Feb-2023), 0240 (exp 22-Mar-2023), or 0250 (exp 26-Apr-2023) are affected.
Identify if your VITROS calibrators have data release versions 6213 through 6218 and the specified lot numbers.
The assay data disks have two calibrator levels set incorrectly, which can cause delayed patient test results.
Check for data release versions 6213 through 6218 and lot numbers 0230 (exp 22-Feb-2023), 0240 (exp 22-Mar-2023), or 0250 (exp 26-Apr-2023).
No immediate stop is required; you should check if your calibrators are affected and take action if they are.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1396-2023 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.
