BD Phoenix PMIC-110 Recalled for False SXT Resistance Results
Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant risk of reduced treatment effectiveness for infections, which aligns with the 'Severe' criteria for significant injury or health risk reports.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC-110 In Vitro Diagnostic (IVD) device, Catalog Number 449036. This device is intended for the in vitro rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus genera. The recall covers 253,575 units distributed nationwide.
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.
Healthcare facilities and laboratories that use this device should stop using the affected units and contact Becton Dickinson & Co. for further instructions. The recall includes all unexpired lots with UDI 00382904490362.
The recalled product
- Product
- BD Phoenix PMIC-110: 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: 449036:
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 253,575
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: 00382904490362
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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