Events

Recall of Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73658
  • Event Risk Class
    Class 2
  • Event Number
    Z-1921-2016
  • Event Initiated Date
    2016-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144671
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Susceptibility test powders, antimicrobial - Product Code JTT
  • Reason
    Individual bottles of product may produce weak beta-lactamase reactions. use may result in delayed or false negative reporting.
  • Action
    Customers were notified by letter beginning on March 24, 2016.

Device

Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch)
  • Model / Serial
    Lot 1717357 Exp: 31Aug2017
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution in MO.
  • 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
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA