Class 2 Device Recall Trinity Biotech USA

• Date Initiated by Firm: March 17, 2021
• Create Date: April 27, 2021
• Recall Status: Terminated on June 29, 2022
• Recall Number: Z-1503-2021
• Recall Event ID: 87637
• 510(K)Number: K140455
• Product Classification: Enzyme linked immunoabsorbent assay, rubeola IgM - Product Code PCL
• Product: 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.
• Code Information: Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
• FEI Number: 1318354
• Recalling Firm/ Manufacturer: Clark Laboratories, Inc.; 2823 Girts Rd; Jamestown NY 14701-9666
• For Additional Information Contact: Rich Eckloff; 716-485-4900 Ext. 2416
• Manufacturer Reason for Recall: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
• FDA Determined Cause: Under Investigation by firm
• Action: 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).
• Quantity in Commerce: 80 kits
• Distribution: Worldwide distribution - US Nationwide distribution and the country of Ireland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PCL