Agency classClass IIOur severity:High FDA (Devices)·Z-0763-2021·Announced 2021-01-06

BD Phoenix PMIC-108 Recalled for False SXT Resistance Results

Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective 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 and involves a risk of harm (reduced treatment effectiveness) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Co. is recalling the BD Phoenix PMIC-108 In Vitro Diagnostic (IVD) device, Catalog Number 448418. This device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus genera. The recall covers 60,425 units distributed nationwide, specifically all unexpired lots with UDI 00382904484187.

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 reduction in the effectiveness of the treatment for the infection.

Healthcare facilities and laboratories that possess this product should stop using it and contact Becton Dickinson & Co. for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

Product: 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
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
treatment-failure
Affected units: 60,425

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: 00382904484187

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 →

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