FDA Device recall Z-0624-2019
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing… by Clark Laboratories Dba Trinity Biotech Usa, citing lack of 510K.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0624-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-01 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Clark Laboratories Dba Trinity Biotech Usa |
| Distribution | AZ, IL, MD, NJ, UT, WV |
Product
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Reason
lack of 510K
Identifiers
| code_info | all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - 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 - 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 - 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 - 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
All Clark Laboratories Dba Trinity Biotech Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0624-2019%22
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