BD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
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 is classified as FDA Class II. The hazard involves a diagnostic error that could lead to ineffective treatment of infections, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic (IVD) device, catalog number 448607. The device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus. The recall covers 69,275 units distributed nationwide.
The recall was initiated because the device may produce false resistant results for Sulfamethoxazole-trimethoprim (SXT) when testing S. aureus. This error could lead to a potential loss of access to a preferred antibiotic regimen and a 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 for further instructions. The recall includes all unexpired lots with UDI 00382904486075.
The recalled product
- Product
- BD Phoenix PMIC/ID-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: 448607
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 69,275
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: 00382904486075
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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