Ortho-Clinical recalls VITROS CoV2 Ag calibrator (Product Code 619995:10758750033591) due to potential calibration failures when used with SARS-CoV-2 Ag Reagent Packs. Affected units may show incorrect test results.
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
Ortho-Clinical is recalling VITROS CoV2 Ag calibrators that could fail to calibrate properly when used with SARS-CoV-2 Ag Reagent Packs. This might lead to inaccurate test results for COVID-19 tests.
The calibrator may fail to calibrate correctly when used with specific SARS-CoV-2 Ag Reagent Packs, leading to inaccurate test results. This could cause false negatives or positives in COVID-19 testing.
Users of VITROS CoV2 Ag calibrators (Product Code 6199950) with Lot 20 who perform COVID-19 tests. Laboratory staff and healthcare workers using these devices are most at risk.
Check for Product Code 6199950 with Lot 20 (Unique Identifier 10758750033591). The calibrator is used in labs for COVID-19 testing with VITROS SARS-CoV-2 Ag Reagent Packs.
Verify if the calibrator shows correct calibration codes when used with the SARS-CoV-2 Ag Reagent Pack.
Ortho-Clinical confirmed potential calibration failures when this calibrator is used with specific SARS-CoV-2 Ag Reagent Packs, which could lead to inaccurate test results.
Check if your calibrator shows correct calibration codes when used with the SARS-CoV-2 Ag Reagent Pack. If issues occur, contact Ortho-Clinical for further guidance.
The recall does not specify a fix; users should check calibration status and contact Ortho-Clinical if problems arise.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1688-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1688-2021 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.
