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Terminated

Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator

FDA Recall Z-1481-04 · Posted 2004-09-21

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeJOJ
Date Initiated2003-09-04
Date Terminated2005-01-04
Product Quantity95783 cases

Reason for Recall

Performance failure complaints.

Firm Action

Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.

Root Cause

Other

Distribution Pattern

Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991709BROWNE CIDEX OPA INDICATORAlbert Browne , Ltd. · 1999-10-08

Official Source

View FDA Recall →

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

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