Events

Recall of Device Recall AMS BUN UREA NITROGEN

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

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
    67599
  • Event Risk Class
    Class 2
  • Event Number
    Z-1267-2014
  • Event Initiated Date
    2014-02-11
  • Event Date Posted
    2014-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125818
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Marketing the devices outside 510(k) requirements.
  • Action
    AMS Diagnostics sent a Recall Notification letter dated February 11, 2014 to all affected customers. The letter instructed the customers to: 1) Review their inventory for the lots listed and if they currently have them, to discard and notify the firm for a replacement. 2) If they don't have the lots listed, please check the box, sign, date and return the letter via fax at (954) 217-0046 or email to dj@amsdiagnostics.com. Customers with questions were instructed to call 954-217-0040 ext. 302. For questions regarding this recall call 954-217-0040.

Device

Device Recall AMS BUN UREA NITROGEN
  • Model / Serial
    Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
  • Product Description
    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum || Quantitative determination of Bun in serum.
  • Manufacturer
    AMS Diagnostics, LLC

Manufacturer

AMS Diagnostics, LLC
  • Manufacturer Address
    AMS Diagnostics, LLC, 1790 N Commerce Pkwy, Weston FL 33326-3204
  • Source
    USFDA