FDA-Device2016-09-21Class III
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
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).
Sold states
Distribution to US nationwide including California, and China (Hong Kong).
Affected count
US: 6 kits, Foreign: 50 kits
Manufactured in
2823 Girts Rd, N/A, Jamestown, NY, United States
Products
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2016Don't want to check this manually?
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