Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA) appears in FDA public data with 9 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0622-2019, Class II) was initiated on November 1, 2018.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0622-2019 | Class II | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromat | November 1, 2018 |
| Z-0620-2019 | Class II | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance | November 1, 2018 |
| Z-0621-2019 | Class II | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid | November 1, 2018 |
| Z-0623-2019 | Class II | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromat | November 1, 2018 |
| Z-0624-2019 | Class II | Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid c | November 1, 2018 |
| Z-2782-2016 | Class III | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD | July 11, 2016 |
| Z-0819-2015 | Class III | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 | November 17, 2014 |
| Z-0572-2014 | Class II | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative dete | August 27, 2013 |
| Z-2445-2012 | Class III | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. | May 29, 2012 |