FDA Enforcement
Class II
Terminated
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Recall: Z-0623-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0623-2019
- Event ID
- 81488
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- November 1, 2018
- Classification Date
- December 18, 2018
- Termination Date
- June 21, 2022
- Address
- 2823 Girts Rd, Jamestown, NY, 14701-9666, United States
Description
Genesys 2 Reagent, REF 01-03-0022 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
Code Info
all serial numbers
Distribution
IL, WV, NJ, AZ, MD, UT
Quantity
216 units