Trinity Biotech Captia Measles IgM, REF/Product Code… recallZ-2782-2016 · Clark Laboratories, Inc. (dba,Trinity Biotech USA) · initiated Jul 11, 2016
Class III Terminated All recalls posted in September 2016
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. (dba,Trinity Biotech USA) 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
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).
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2782-2016
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Jul 11, 2016
- Posted by the FDA
- Sep 12, 2016
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Quantity
- US: 6 kits, Foreign: 50 kits
- Product code
- PCL
- FDA submissions
- K140455
- Distribution
- Distribution to US nationwide including California, and China (Hong Kong).
Product description
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Code information (models, lots, serial numbers)
Lot Number 2326060-043, Expiration Date 31 May 2017
Other devices under the same FDA submission
1 device cleared under K140455 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 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 18, 2026. Text above is shown as published by the FDA.
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