Lower riskMedical device recall · FDA · Published September 10, 2021
Ortho Clinical Diagnostics VITROS SARS-CoV-2 IgG Controls May Give Delayed Results
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.
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. Read more at govinfonow.com/recall/61814-ortho-clinical-diagnostics-vitros-sars-cov-2-igg-controls-may.
“Ortho Clinical Diagnostics VITROS SARS-CoV-2 IgG Controls May Give Delayed Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61814-ortho-clinical-diagnostics-vitros-sars-cov-2-igg-controls-may. Based on FDA recall #Z-0120-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0120-2022%22&limit=1).
The FDA announced on 2021-09-10 that Ortho Clinical Diagnostics Inc recalled VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls due to potential for delayed results. The agency classified the recall as Class II.
The recalled controls are outside of the expected control range, which may lead to delayed results. The FDA issued a Class II classification for this recall.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall: Calibration Failures Affect Test Results (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall: Calibration Failures Risk Patient Delay (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12).
How to tell if you have this one
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.
Brand
Ortho Clinical Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code (6199966) and lot number (0040) on the control vials.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Idaho, Kansas, Kentucky, Louisiana, Maine, Michigan, Mississippi, Missouri, New York, Tennessee, Texas, West Virginia.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0120-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0120-2022 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.