Recall Z-0712-03 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Sybron Dental Specialties
Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
| Date | Apr 9, 2003 (initiated Feb 25, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922481 | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE Board of Directors, Albert Browne , Ltd., Jun 2, 1994 |