BD Phoenix PMIC-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.
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 agency classification is Class II, and the source text explicitly states that the defect could lead to a 'potential reduction in effectiveness of treatment of the infection,' which aligns with the rubric criterion for significant injury or adverse health consequences.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC-107 In Vitro Diagnostic (IVD) device, Catalog Number 448417. The device is intended for the in vitro rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus. The recall covers 103,475 units distributed nationwide, including all unexpired lots with UDI 00382904484170.
The recall is due to a potential for false resistant results for Sulfamethoxazole-trimethoprim (SXT) in S. 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 have purchased or are using this device should stop using it and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Phoenix PMIC-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: 448417
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 103,475
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: 00382904484170
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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