Z-1481-04

Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator

Name: Z-1481-04 Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
Creator: Advanced Sterilization Products
Published: 2003-09-04
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2003-09-04 / Terminated

FDA source

Advanced Sterilization Products began a recall of Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator on 2003-09-04. The reason FDA records is "Performance failure complaints". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1481-04
Status: Terminated
Initiated: 2003-09-04
Posted: 2004-09-21
Terminated: 2005-01-04
Recalling firm: Advanced Sterilization Products
Product: Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Performance failure complaints.
FDA root cause: Other
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.
Quantity in commerce: 95783 cases
Distribution: Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
Product codes and lots: CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272 CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000

Product code JOJ

K991709Class IIBrowne Cidex Opa IndicatorAlbert Browne , Ltd. / cleared 1999-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)