FDA Recall
Terminated
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Recall: Z-1921-2016
·
Initiated March 24, 2016
Recall
- Recall Number
- Z-1921-2016
- Event Number
- 73658
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- JTT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 24, 2016
- Terminated
- February 13, 2017
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Reason
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Action
Customers were notified by letter beginning on March 24, 2016.
Distribution
US distribution in MO.
Quantity
2 units were imported and distributed domestically