Device product
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Z-1525-2013
Product summary
- Event
- Event 65188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 683 units
- Official record key
device-enforcement:Z-1525-2013
Official wording
Reason: The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Code information: Lot: 2013-11-13, Exp 11/13/2013.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.