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BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive...

FDA Recall #Z-0763-2021 — Class II — December 8, 2020

Recall #Z-0763-2021 Date: December 8, 2020 Classification: Class II Status: Terminated

Product Description

BD Phoenix PMIC-108: 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: 448418

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

60425 eaches

Distribution

Nationwide

Code Information

All unexpired lots UDI: 00382904484187

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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