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

Recall Z-2776-2020 — Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

U.S. FDA — Device Enforcement · United States · 2020-06-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2776-2020
Date of alert: 2020-06-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Luminex Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840487101483

Reported risk: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

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-2776-2020 — Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

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