Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060… recallZ-1503-2021 · Clark Laboratories, Inc. · initiated Mar 17, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Clark Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-1503-2021
- Status
- Terminated
- Initiated by the company
- Mar 17, 2021
- Recalling firm
- Clark Laboratories, Inc.
- Quantity
- 80 kits
- Product code
- PCL
- FDA submissions
- K140455
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Ireland.
Product description
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 (models, lots, serial numbers)
Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Trinity Biotech 2326060Clark Laboratories, Inc. · Enzyme Linked Immunoabsorbent Assay, Rubeola Igm1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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