Events

Recall of Anaerotest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EMD Chemicals 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
    37215
  • Event Risk Class
    Class 3
  • Event Number
    Z-0498-2007
  • Event Initiated Date
    2006-08-17
  • Event Date Posted
    2007-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50124
  • 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
    Micro Test Rolls - Product Code J TX
  • Reason
    Lot # oc553145 of anaerotest failed to remain in specification. qc indicator shows an anaerobic environment even if oxygen is present.
  • Action
    A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.

Device

Anaerotest
  • Model / Serial
    Item number 1.19034.0002 Lot # OC553145
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
  • Product Description
    Anaerotest for microbiology || Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes || Merck KgaA || 64271 Darmstadt, Germany || 1.19034.0002 17.08.06 1 unit || UPC 4 022536 667928
  • Manufacturer
    EMD Chemicals Inc

Manufacturer

EMD Chemicals Inc
  • Manufacturer Address
    EMD Chemicals Inc, 480 S Democrat Rd, Gibbstown NJ 08027-1239
  • Source
    USFDA