Reported Jul 23, 2025 · Ongoing
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- Brand NameVITROS
- Chemistry Products Product NameVITROS Chemistry Products Performance
- Verifier II Model/Catalog Number8231474
- Software VersionN/A
- Product DescriptionVITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added
- ComponentNo, not a component
- Lot codes and dates
- Lot CodeProduct
- Code823 1474 (UDI: 10758750004577)
- Lots currently within expiryW1667- Exp. 8/14/2025 X1901 - Exp. 11/20/2025 A2114 - Exp. 3/25/2026 D2338 - Exp. 6/3/2026 F2830 - Exp. 2/3/2027
- Amount recalled
- 36005 Units (US)/22,302 units OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
This product could cause temporary or reversible health problems — stop using it.
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