Events

Recall of Device Recall Remel MH w/oxacillin superpack cs/ 500 seg/flask, ref R01626

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

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
    80068
  • Event Risk Class
    Class 2
  • Event Number
    Z-2137-2018
  • Event Initiated Date
    2018-05-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164353
  • 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
    Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
  • Reason
    Product may fail performance testing for s aureus atcc 43300.
  • Action
    The firm initiated the recall by letter on 05/04/2018. The letter stated the following: "Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action." For questions contact Technical Services Department at 800-255-6730 or 913-888-0939.

Device

Device Recall Remel MH w/oxacillin superpack cs/ 500 seg/flask, ref R01626
  • Model / Serial
    Lot: 307200
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN || Product Usage: || Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
  • Manufacturer
    Thermo Fisher

Manufacturer

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