Medical device manufacturer, Advanced Sterilization Products, has issued a medical device safety alert concerning its CIDEX OPA Solution Test Strips
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. According to the manufacturer, 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. The manufacturer advises users to check the expiration date on all affected products. Affected users are also advised to update the expiry date from 12 to 10 months.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 April 2015