Genesys Analytical Column — Class II medical device recall Z-0621-2019
Terminated recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), reported 2018-12-26, distributed in AZ, IL, MD, NJ, UT, WV. lack of 510K
| Recall number | Z-0621-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA), Jamestown, NY, United States |
| Recall initiated | 2018-11-01 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2022-06-21 |
| Distributed | AZ, IL, MD, NJ, UT, WV |
| Quantity | 372 units |
| Model numbers | 01-05-0017 |
Product
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Reason for recall
lack of 510K
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0621-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.