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Terminated

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

FDA Recall Z-0712-03 · Posted 2003-04-09

Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeJOJ
Date Initiated2003-02-25
Date Terminated2004-05-17
Product Quantity4,112 cases of two bottles each. 60 strips per bottle.

Reason for Recall

Moisture ingress into packaging of test strips may cause premature failure.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922481BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDEBoard of Directors, Albert Browne , Ltd. · 1994-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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