BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positiv...

FDA Recall #Z-0765-2021 — Class II — December 8, 2020

Recall #Z-0765-2021 Date: December 8, 2020 Classification: Class II Status: Terminated

Product Description

BD Phoenix" PMIC-109: 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: 448419

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

31900 eaches

Distribution

Nationwide

Code Information

All unexpired lots UDI: 00382904484194

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

Back to All Device Recalls