Device product
BD Phoenix PMIC/ID-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: 448609
Z-0764-2021
Product summary
- Event
- Event 86963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34650 eaches
- Official record key
device-enforcement:Z-0764-2021
Official wording
Reason: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Code information: All unexpired lots UDI: 00382904486099
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection