Events

Recall of Device Recall Thermo Scientific VersaTREK REDOX 1, Ref 710244

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
    68583
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2014
  • Event Initiated Date
    2014-06-11
  • Event Date Posted
    2014-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128265
  • 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
    System, blood culturing - Product Code MDB
  • Reason
    Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of streptococcus pneumoniae.
  • Action
    The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.

Device

Device Recall Thermo Scientific VersaTREK REDOX 1, Ref 710244
  • Model / Serial
    Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
  • Product Description
    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
  • 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