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Recall Observatory FDA recall evidence

Device product

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

Z-1454-2015

March 15, 2015

Class II

Product summary

Firm
Focus Diagnostics Inc
Event
Event 70856
Status
Terminated
Classification
Class II
Quantity
300 units
Official record key
device-enforcement:Z-1454-2015

Official wording

Reason: 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.

Code information: Lot No. 27333

Distribution pattern: Internationally: Denmark only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.