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Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Recalled September 21, 2016 · FDA recall Z-2782-2016 · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
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 Class III
Units
US: 6 kits, Foreign: 50 kits
Sold at
Distribution to US nationwide including California, and China (Hong Kong).
Description
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).
Product
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Manufacturer(s)
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →