BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-posit...
FDA Recall #Z-0760-2021 — Class II — December 8, 2020
Product Description
BD Phoenix PMIC/ID-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: 448607
Reason for Recall
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
Recalling Firm
Becton Dickinson & Co. — Sparks, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
69275 eaches
Distribution
Nationwide
Code Information
All unexpired lots UDI: 00382904486075
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated