Events

Recall of Device Recall Northeast Laboratory Services (NEL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Northeast Laboratory Services, 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
    73325
  • Event Risk Class
    Class 2
  • Event Number
    Z-1313-2016
  • Event Initiated Date
    2015-12-21
  • Event Date Posted
    2016-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143873
  • 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, selective and differential - Product Code JSI
  • Reason
    Product marketed without a 510 (k).
  • Action
    Northeast Laboratory services issued recall letter dated 2/29/16 and advised users to: Immediately examine your inventory for all lots of these products you may have in stock. Please destroy all remaining product in stock. Users requested to fill out the questionnaire immediately and return the questionnaire via email or Fax. Previously Northeast Laboratory Services notified users by letter dated 12/21/15 that the firm has discontinued the products effective January 2016. Alternative products were referenced in the letter for users to transition to replacement product.

Device

Device Recall Northeast Laboratory Services (NEL)
  • Model / Serial
    Al lot codes
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube || Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
  • Manufacturer
    Northeast Laboratory Services, Inc.

Manufacturer

Northeast Laboratory Services, Inc.