Z-1503-2021Class II

Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 -

Name: Z-1503-2021 Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 -
Creator: Clark Laboratories, Inc.
Published: 2021-03-17
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2021-03-17 / Terminated

FDA source

Clark Laboratories, Inc. began a recall of Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of... on 2021-03-17. FDA classified it as Class II and gives the reason as "Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1503-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-17
Posted: 2021-04-27
Terminated: 2022-06-29
Recalling firm: Trinity Biotech USA
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.
Product code: PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Reason for recall: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
FDA 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 in commerce: 80 kits
Distribution: Worldwide distribution - US Nationwide distribution and the country of Ireland.
Product codes and lots: Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1503-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1503-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27

Product code PCL

K140455Class ICaptia Measles IgmTrinity Biotech USA / cleared 2014-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)