Ortho Clinical Diagnostics VITROS Performance Verifier II recall: Refrigerated stability
Ortho Clinical Diagnostics recalls VITROS Performance Verifier II Lot K4852 due to refrigerated stability problems for AST analyte. Affected units may not remain stable after 6 months in the fridge.
Lower-risk recall
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
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What happened, in plain English
Ortho Clinical Diagnostics is recalling VITROS Performance Verifier II (PVII) Lot K4852 because it doesn't stay stable when stored in the refrigerator for up to six months. This could affect the accuracy of AST analyte tests in certain lab equipment. Read more at govinfonow.com/recall/73447-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-refrigerated-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/73447-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-refrigerated-stability · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0807-2018
Cite this page
“Ortho Clinical Diagnostics VITROS Performance Verifier II recall: Refrigerated stability.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73447-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-refrigerated-stability. Based on FDA recall #Z-0807-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0807-2018%22&limit=1).
Why it’s dangerous
The VITROS Performance Verifier II (PVII) Lot K4852 does not maintain stability for the AST analyte when stored in the refrigerator for up to six months. This means the product may not provide accurate test results after this time period, potentially affecting lab results.
Who’s affected
Lab users of VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems who have Lot K4852 (expired Feb 2018) are affected. Those using the product for AST analyte testing in refrigerated conditions are most at risk.
How to tell if you have this one
Check for the product name 'VITROS Performance Verifier II' and lot number K4852. The product was sold with an expiration date of February 22, 2018.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
What to do — step by step
Check Product Details
Identify if your VITROS Performance Verifier II has lot number K4852 and was sold with an expiration date of February 22, 2018.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0807-2018 (July 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0807-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.