FDA Medical Device Recalls (openFDA)
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 number
- Z-1503-2021
- Recalling firm
- Clark Laboratories, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2021-03-17
- Posted
- not on file
- Terminated
- 2022-06-29
- Reason
- Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
- Root 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
- 80 kits
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Ireland.
- Lot, serial or model codes
- Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
- 510(k) numbers
- ["K140455"]
- PMA numbers
- not on file
- Product code
- PCL
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28