Ortho-Clinical SARS-CoV-2 IgG Reagent Pack Recall: On-Analyzer Stability Issue
Ortho-Clinical recalls SARS-CoV-2 IgG Quantitative Reagent Packs due to incorrect on-analyzer stability time in instructions. This affects lab use on VITROS systems. No action needed per recall.
Lower-risk recall
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Contact the company
What happened, in plain English
Ortho-Clinical is recalling SARS-CoV-2 IgG reagent packs used in lab testing because the instructions incorrectly state the reagent stays stable for 8 weeks on the analyzer when it should be 6 weeks. This means labs might get inaccurate test results if they use the reagent beyond its actual stability period. Read more at govinfonow.com/recall/60581-ortho-clinical-sars-cov-2-igg-reagent-pack-recall-on.
Source Summary by GovInfoNow · govinfonow.com/recall/60581-ortho-clinical-sars-cov-2-igg-reagent-pack-recall-on · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1367-2022
Cite this page
“Ortho-Clinical SARS-CoV-2 IgG Reagent Pack Recall: On-Analyzer Stability Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60581-ortho-clinical-sars-cov-2-igg-reagent-pack-recall-on. Based on FDA recall #Z-1367-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2022%22&limit=1).
Why it’s dangerous
The reagent's on-analyzer stability (OAS) time is listed as 8 weeks in the instructions, but it actually degrades after 6 weeks. This could lead to inaccurate test results if the reagent is used beyond its actual stability period.
Who’s affected
Labs using Ortho-Clinical's SARS-CoV-2 IgG reagent packs on VITROS ECi/ECiQ/3600 or 5600/XT 7600 systems. Lab technicians and healthcare facilities that handle these tests are most at risk.
How to tell if you have this one
Check for product code 6199960 or UDI-DI 10758750034413 on the reagent pack. The reagent is intended for use on VITROS ECi/ECiQ/3600 or 5600/XT 7600 systems. All lots, including expired and future releases, are affected.
- Brand
Ortho-Clinical- Category
Medical device
What to do — step by step
Check Reagent Code
Look for product code 6199960 or UDI-DI 10758750034413 on the reagent pack.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.” 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 published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1367-2022 (May 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1367-2022 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.