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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00298-1
Product Name/Description	CIDEX OPA Solution Test Strips ARTG number: 224738
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	1/04/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	The manufacturer has determined that shelf life data for the CIDEX OPA Solution Test Strips is effective for only 10 months of the test strip’s labeled 12-month shelf life. There is no potential risk to patient safety, as test strips used at the end of shelf life would indicate a false negative (e.g. “Fail” result for solution above the Minimum Effective Concentration). This issue could be observed during either QC testing of the test strips prior to use (in accordance with the instructions for use) or during testing of CIDEX OPA Solution when the test strips are near the end of shelf life. There was no evidence that a false positive (e.g. a “Pass” result for solutions below the MEC) would occur. A corrective action is in place to update the shelf life of the CIDEX® OPA Solution Test Strips from 12 months to 10 months.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers are requested to update the expiry date from 12 to 10 months. This action has been closed-out on 03/03/2016.
Contact Information	1800 252 194 - Johnson & Johnson Medical Customer Service