Z-2782-2016Class III

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Name: Z-2782-2016 Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Creator: Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Published: 2016-07-11
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2016-07-11 / Terminated / root cause: manufacturing process

FDA source

Clark Laboratories, Inc. (dba,Trinity Biotech USA) began a recall of Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD on 2016-07-11. FDA classified it as Class III and gives the reason as "The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2782-2016
Classification: Class III
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-09-12
Terminated: 2017-05-09
Recalling firm: Trinity Biotech USA
Product: Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Product code: PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Reason for recall: The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all 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. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.
Quantity in commerce: US: 6 kits, Foreign: 50 kits
Distribution: Distribution to US nationwide including California, and China (Hong Kong).
Product codes and lots: Lot Number 2326060-043, Expiration Date 31 May 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2782-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2782-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-12

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)