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

Recall Z-1334-2022 — Verigene CDF Nucleic Acid Test, Part No. 30-002-22

U.S. FDA — Device Enforcement · United States · 2022-06-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1334-2022
Date of alert: 2022-06-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Luminex Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840487101735

Reported risk: There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

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

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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-1334-2022 — Verigene CDF Nucleic Acid Test, Part No. 30-002-22

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