FDA Medical Device Recalls (openFDA)
Sybron Dental Specialties: Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
- Recall number
- Z-0712-03
- Recalling firm
- Sybron Dental Specialties
- Product
- Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
- Status
- Terminated
- Initiated
- 2003-02-25
- Posted
- 2003-04-09
- Terminated
- 2004-05-17
- Reason
- Moisture ingress into packaging of test strips may cause premature failure.
- 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
- 4,112 cases of two bottles each. 60 strips per bottle.
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K922481"]
- PMA numbers
- not on file
- Product code
- JOJ
- Firm FEI
- 3001168737
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28