Device product
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Z-2599-2018
Product summary
- Event
- Event 80330
- Status
- Terminated
- Classification
- Class II
- Quantity
- 686 boxes
- Official record key
device-enforcement:Z-2599-2018
Official wording
Reason: The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Code information: Lot 2018-11-03
Distribution pattern: NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
Derived failure modes
-
Unknown
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.