BD Phoenix PMIC/ID-108 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-108 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 risk-of-harm product (medical device) where the hazard is a potential reduction in treatment effectiveness due to false test results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC/ID-108 in vitro diagnostic (IVD) device, catalog number 448608. This device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus genera.
The recall is due to the potential for the device to produce false resistant results for Sulfamethoxazole-trimethoprim (SXT) when testing Staphylococcus aureus. A false resistant result could lead to a loss of access to a preferred antibiotic regimen and a potential reduction in the effectiveness of treating the infection.
The recall covers 34,825 units distributed nationwide. All unexpired lots are affected, identified by UDI 00382904486082. Healthcare facilities and laboratories should stop using the affected devices and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- BD Phoenix PMIC/ID-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: 448608
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 34,825
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: 00382904486082
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.
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