Agency classClass IIOur severity:High FDA (Devices)·Z-0759-2021·Announced 2021-01-06

BD Phoenix PMIC/ID-105 Recalled for False SXT Resistance Results

Becton Dickinson is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may lead to ineffective treatment of infections, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Co. is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic (IVD) device. This device is intended for the in vitro rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus. The recall applies to all unexpired lots of Catalog Number 448605, which is a discontinued product.

The recall was initiated because the device may produce false resistant results for Sulfamethoxazole-trimethoprim (SXT) when testing Staphylococcus aureus. This error could lead to a potential loss of access to a preferred antibiotic regimen and a potential reduction in the effectiveness of treatment for the infection.

The recall is distributed nationwide. Healthcare facilities and laboratories using this device should stop using the affected lots and contact Becton Dickinson for further instructions.

The recalled product

Product: BD Phoenix PMIC/ID-105: 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: 448605 (Discontinued)
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
treatment-ineffectiveness

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All unexpired lots UDI: 00382904486051

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Becton Dickinson & Co.

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