Clark Laboratories Dba Trinity Biotech Usa recalls
Clark Laboratories Dba Trinity Biotech Usa appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2018-12-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2012-10-03 to 2018-12-26 |
| By agency | FDA Device (9) |
| By classification | Class II (6), Class III (3) |
| By status | terminated (9) |
| Distribution named in notices | AZ, CA, FL, IL, MD, NJ, NY, US, UT, WV |
Recalls
- Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employin…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa
Reason: lack of 510K - ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems e…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa
Reason: lack of 510K - Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion ex…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa
Reason: lack of 510K - Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa
Reason: lack of 510K - Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion ex…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa
Reason: lack of 510K - Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA Device · Class III · 2016-09-21 · Clark Laboratories Dba Trinity Biotech Usa
Reason: 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). - Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagno…
FDA Device · Class III · 2014-12-24 · Clark Laboratories Dba Trinity Biotech Usa
Reason: Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months. - Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in s…
FDA Device · Class II · 2014-01-01 · Clark Laboratories Dba Trinity Biotech Usa
Reason: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. - Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests
FDA Device · Class III · 2012-10-03 · Clark Laboratories Dba Trinity Biotech Usa
Reason: The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.