Events

Recall of Device Recall PathoDx Strep B Grouping Latex

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
    71614
  • Event Risk Class
    Class 2
  • Event Number
    Z-2351-2015
  • Event Initiated Date
    2015-06-30
  • Event Date Posted
    2015-08-07
  • 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=138408
  • 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
    Antigens, all groups, streptococcus spp. - Product Code GTY
  • Reason
    A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
  • Action
    On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.

Device

Device Recall PathoDx Strep B Grouping Latex
  • Model / Serial
    lot 1463129, exp. date 31 May 2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Product Description
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. || Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
  • 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