—#144671

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

FDA product code: JTT — Susceptibility Test Powders, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot 1717357 Exp: 31Aug2017

Why it was recalled

Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Customers were notified by letter beginning on March 24, 2016.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US distribution in MO.

Timeline

Recall initiated: 2016-03-24
Terminated: 2017-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144671. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.