Z-0712-03

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

Name: Z-0712-03 Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck...
Creator: Sybron Dental Specialties
Published: 2003-02-25
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2003-02-25 / Terminated / root cause: packaging

FDA source

Sybron Dental Specialties began a recall of Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8% on 2003-02-25. The reason FDA records is "Moisture ingress into packaging of test strips may cause premature failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0712-03
Status: Terminated
Initiated: 2003-02-25
Posted: 2003-04-09
Terminated: 2004-05-17
Recalling firm: Sybron Dental Specialties, Inc.
Product: Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Moisture ingress into packaging of test strips may cause premature failure.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 4,112 cases of two bottles each. 60 strips per bottle.
Distribution: Nationwide and Canada.
Product codes and lots: 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 code JOJ

K922481Class IIBrowne Ga Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne , Ltd. / cleared 1994-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)