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

Recall Z-0548-2014 — FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro d

U.S. FDA — Device Enforcement · United States · 2013-11-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0548-2014
Date of alert: 2013-11-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Qualigen Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 25000041

Reported risk: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

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.