Clark Laboratories, Inc. (dba,Trinity Biotech USA): Medical Device Recall in 2016 - (Recall #: Z-2782-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: July 11, 2016

Date Posted: September 21, 2016

Recall Number: Z-2782-2016

Event ID: 74932

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).

Status: Terminated

Product Quantity: US: 6 kits, Foreign: 50 kits

Code Information:

Lot Number 2326060-043, Expiration Date 31 May 2017

Distribution Pattern:

Distribution to US nationwide including California, and China (Hong Kong).

Voluntary or Mandated:

Voluntary: Firm initiated