Recall Z-1921-2016— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2016-03-24, terminated 2017-02-13. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-24
- Terminated
- 2017-02-13
- Firm location
- Lenexa, KS, United States
Product 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 for recall
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Data sourced from openFDA. This site is unofficial and independent of the FDA.