Agency classClass IIOur severity:High FDA (Devices)·Z-0760-2021·Announced 2021-01-06

BD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results

Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 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 is classified as FDA Class II. The hazard involves a diagnostic error that could lead to ineffective treatment of infections, which fits the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Co. is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic (IVD) device, catalog number 448607. The device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus. The recall covers 69,275 units distributed nationwide.

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

Healthcare facilities and laboratories that use this device should stop using the affected units and contact Becton Dickinson for further instructions. The recall includes all unexpired lots with UDI 00382904486075.

The recalled product

Product: 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
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
diagnostic-error
Affected units: 69,275

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: 00382904486075

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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