Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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

FDA Recall Z-1921-2016 · Posted None

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTT
Date Initiated2016-03-24
Date Terminated2017-02-13
Product Quantity2 units were imported and distributed domestically

Reason for Recall

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

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution in MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑