Events

Recall of Device Recall Remel Spectra MRSA

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
    59005
  • Event Risk Class
    Class 2
  • Event Number
    Z-2677-2011
  • Event Initiated Date
    2011-05-11
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100816
  • 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, excluding mueller hinton agar - Product Code JSO
  • Reason
    The product failed to prevent growth of methicillin-sensitive staphylococcus aureus (mssa).
  • Action
    Remel, Inc. sent an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letter, dated May 10, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory and discard all remaining product lots. Additionally, customers are to complete the Product Inventory Checklist and indicate whether or not they desire replacement of the product or credit. A self-addressed , stamped envelope was enclosed in the letter to use to return the checklist. Questions can be answered by contacting the Technical Services Department at 800-255-6730 or 913-888-0939.

Device

Device Recall Remel Spectra MRSA
  • Model / Serial
    Cat. # R01821 (10 pack) - Lot 028251, exp. 2011.06.13;  Cat. #R01822 (100 pack) - Lot 028252, exp. 2011.06.13; 028883, exp. 2011.06.14; 028884, exp. 2011.06.14; and 031922, exp. 2011.06.21
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution--including Puerto Rico.
  • Product Description
    Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. || The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain.
  • 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