PlainRecalls
FDA Devices Moderate Class II 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

Reported: June 15, 2016 Initiated: March 24, 2016 #Z-1921-2016

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.

Details

Recalling Firm
Remel Inc
Units Affected
2 units were imported and distributed domestically
Distribution
US distribution in MO.
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic. Recalled by Remel Inc. Units affected: 2 units were imported and distributed domestically.
Why was this product recalled?
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1921-2016.