Events

Recall of Gluteraldehyde Concentration Indicators. || MetriTest 1.5% and MetriTest 1.8%, also || OmniChek 1.5% and OmniCheck 1.8%

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybron Dental Specialties.

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
    25811
  • Event Risk Class
    Class 3
  • Event Number
    Z-0712-03
  • Event Initiated Date
    2003-02-25
  • Event Date Posted
    2003-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26509
  • 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
    Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
  • Reason
    Moisture ingress into packaging of test strips may cause premature failure.
  • Action
    Notice was sent to customers of the potential problem on 3/7/2003. The notice included directions to perform a Modified Quality Control Procedure. Instructions are to test strips function each day.

Device

Gluteraldehyde Concentration Indicators. || MetriTest 1.5% and MetriTest 1.8%, also || OmniChek 1...
  • Model / Serial
    MetriTest 1.5%, part number 10-303, lot numbers: 007917, 007919, 008184, 008325, 008665, 009100. MetriTest 1.8%, part number 10-304, lot numbers: 009101, 009121, 009144, 009249.  OmniChek G 1.5%, part number 10-313, lot 009091. OmniChek G 1.8%, part number 10-313, lot 009102.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Gluteraldehyde Concentration Indicators. || MetriTest 1.5% and MetriTest 1.8%, also || OmniChek 1.5% and OmniCheck 1.8%
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Manufacturer Address
    Sybron Dental Specialties, 1717 West Collins Avenue, Orange CA 92867
  • Source
    USFDA