FDA Medical Device Recalls (openFDA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA): ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Recall number
- Z-0620-2019
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Product
- ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Status
- Terminated
- Initiated
- 2018-11-01
- Posted
- not on file
- Terminated
- 2022-06-21
- Reason
- lack of 510K
- Root cause
- No Marketing Application
- Action
- The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
- Quantity
- 14 devices
- Distribution
- IL, WV, NJ, AZ, MD, UT
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKA
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28