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.
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
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.
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.
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.
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.
Ensure the kit is stored properly in a cool, dry place and not refrigerated unopened.
The VITROS Chemistry Products Performance Verifier II Lot Q7692 can produce biased ALKP values when stored unopened at refrigerated temperatures.
The recall does not specify a remedy, so check with Ortho Clinical Diagnostics for guidance on handling or replacement.
No, the hazard is limited to inaccurate lab results, not physical injury.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0471-2021 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0471-2021 from Ortho Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
