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

Recall Z-0312-2022 — BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials

U.S. FDA — Device Enforcement · United States · 2021-10-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0312-2022
Date of alert: 2021-10-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BioFire Diagnostics, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00815381020338

Reported risk: Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.

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.

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