BD Phoenix PMIC-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-109 in vitro diagnostic devices because they may produce false resistant results for S. aureus, potentially affecting antibiotic treatment choices.
What this means for you
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 injury has not yet been reported, but the potential for reduced treatment effectiveness fits the 'High' severity criteria for theoretical harm without confirmed illness.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC-109 in vitro diagnostic (IVD) device, catalog number 448419. The device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus genera. The recall covers 31,900 units distributed nationwide, including all unexpired lots with UDI 00382904484194.
The recall is due to a potential for false resistant results for Sulfamethoxazole-trimethoprim (SXT) when testing S. aureus. This error could lead to a loss of access to a preferred antibiotic regimen and a potential reduction in the effectiveness of treating the infection.
Healthcare facilities and laboratories that possess this device should stop using it and contact Becton Dickinson for instructions on return or replacement. Consumers are not directly affected as this is a professional in vitro diagnostic product.
The recalled product
- Product
- BD Phoenix" PMIC-109: 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: 448419
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 31,900
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: 00382904484194
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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