Reported Apr 3, 2024 · Ongoing
VITROS Performance Verifier II
Ortho-Clinical Diagnostics
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 · 1000 Lee Rd · Rochester, NY · 14606-4250
Is this the product you have?
- VITROS Performance Verifier II
- Lot codes and dates
- Product Code8231474
- GTIN
10758750004577Lot No. R1176
- Amount recalled
- 11,224 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
This product could cause temporary or reversible health problems — stop using it.
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