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

Recall Z-0761-2021 — BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417

U.S. FDA — Device Enforcement · United States · 2020-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0761-2021
Date of alert
2020-12-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00382904484170
Reported risk: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
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.