Reported Apr 29, 2015 · Terminated
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In…
Focus 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: Focus Diagnostics Inc · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
- Lot codes and dates
- Lot No. 27333
- Amount recalled
- 300 units
Why it was recalled
Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
This product could cause temporary or reversible health problems — stop using it.
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