Device product
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Z-1921-2016
Product summary
- Firm
- Remel Inc
- Event
- Event 73658
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units were imported and distributed domestically
- Official record key
device-enforcement:Z-1921-2016
Official wording
Reason: Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Code information: Lot 1717357 Exp: 31Aug2017
Distribution pattern: US distribution in MO.
Derived failure modes
-
Unknown
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.