Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
FDA device recall Z-0712-03 · posted 2003-04-09 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- Moisture ingress into packaging of test strips may cause premature failure.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 4,112 cases of two bottles each. 60 strips per bottle.
- Distribution
- Nationwide and Canada.
- Date initiated
- 2003-02-25
- Date posted
- 2003-04-09
- Date terminated
- 2004-05-17
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE (K922481) | Board of Directors, Albert Browne , Ltd. | 1994-06-02 |