Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG Control Recall: Elevated Results
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.
Lower-risk recall
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
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/64133-ortho-clinical-diagnostics-vitros-anti-sars-cov-2-igg-control.
Source Summary by GovInfoNow · govinfonow.com/recall/64133-ortho-clinical-diagnostics-vitros-anti-sars-cov-2-igg-control · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0451-2021
Cite this page
“Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG Control Recall: Elevated Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64133-ortho-clinical-diagnostics-vitros-anti-sars-cov-2-igg-control. Based on FDA recall #Z-0451-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0451-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0450-2021 | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362); Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20 | 651 units |
| Z-0451-2021 | VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355); Lot Number/ Exp. Date: 0110 25-NOV-20 | 691 units (OUS) |
What to do — step by step
Check Product Details
Verify your product code and lot number against the recall information provided.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0451-2021 (September 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0451-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.