Recall Z-1921-2016 ยท JTT Susceptibility Test Powders, Antimicrobial
Remel Inc
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
| Date | Mar 24, 2016 |
| Status | Terminated |
| Reason | Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified by letter beginning on March 24, 2016. |
| Quantity | 2 units were imported and distributed domestically |
| Distribution | US distribution in MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.