Ortho Clinical Diagnostics VITROS Performance Verifier II Recall: Unopened Refrigerated
Ortho Clinical Diagnostics recalls VITROS Chemistry Products Performance Verifier II Lot Q7692 for biased ALKP values when stored unopened at refrigerated temperatures. Affected units may need retesting or replacement.
Lower-risk recall
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
Contact the company
What happened, in plain English
Ortho Clinical Diagnostics is recalling a specific batch of VITROS Chemistry Products Performance Verifier II test kits because they can give inaccurate ALKP results if stored unopened in the refrigerator. This could lead to incorrect lab test results if used without proper handling. Read more at govinfonow.com/recall/64091-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-unopened-refrigerated.
Source Summary by GovInfoNow · govinfonow.com/recall/64091-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-unopened-refrigerated · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0471-2021
Cite this page
“Ortho Clinical Diagnostics VITROS Performance Verifier II Recall: Unopened Refrigerated.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64091-ortho-clinical-diagnostics-vitros-performance-verifier-ii-recall-unopened-refrigerated. Based on FDA recall #Z-0471-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0471-2021%22&limit=1).
Why it’s dangerous
The test kit can produce biased ALKP (alkaline phosphatase) values when stored unopened at refrigerated temperatures. This means lab results might be inaccurate if the kit is used without proper storage conditions.
Who’s affected
Lab technicians and healthcare providers who use VITROS Chemistry Products Performance Verifier II for in vitro diagnostics are most at risk. The affected batch was sold with a specific lot number and expiration date.
How to tell if you have this one
Check for the product code 8231474 and lot number Q7692 on the VITROS Chemistry Products Performance Verifier II. The kit was sold with an expiration date of November 1, 2021.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
What to do — step by step
Check Storage Conditions
Ensure the kit is stored properly in a cool, dry place and not refrigerated unopened.
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, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia,…” 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 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this product?
No, the hazard is limited to inaccurate lab results, not physical injury.
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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-0471-2021 (October 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0471-2021 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.