Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1454-2015 — STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

U.S. FDA — Device Enforcement · United States · 2015-03-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1454-2015
Date of alert: 2015-03-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Focus Diagnostics Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1454-2015 — STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

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