Clark Laboratories, Inc. Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

Recommended Action

Per FDA guidance

Trinity Biotech issued Product Notification Letter on March 17, 2021 stating reason for recall, health risk and action to take: Please note, if a laboratorys test resulted in a valid run, such as all kit Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. Customers are instructed to discontinue the use of any Measles IgM Lot #2326060-060 kits that they may have in their inventory. Please complete the attached fax back form informing us of how many of these kits you and your customers have in your inventory that will require replacement. A thorough investigation into the root cause of this issue has been initiated and any corrective/preventive actions will be implemented as appropriate. If you have any questions or comments arising from this customer communication, the Trinity Biotech Help Desk is ready to answer your questions (800-325-3424, option 2).