Device product
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Z-0570-2013
Product summary
- Event
- Event 63737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,250 tests
- Official record key
device-enforcement:Z-0570-2013
Official wording
Reason: An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Code information: Lot number 2053373
Distribution pattern: Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Derived failure modes
-
Unknown
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.