Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Recall date

July 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2782-2016

FDA classification

Class III

Brand / firm

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Sold / distributed

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

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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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