Z-0622-2019 Class II Terminated
FDA device recall Z-0622-2019 was initiated by Clark Laboratories, Inc. (dba,Trinity Biotech USA) on November 1, 2018 and is designated Class II. Reason for recall: lack of 510K The recall status is terminated (terminated June 21, 2022). Affected quantity: 252 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- November 1, 2018
- Termination Date
- June 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 252 units
Product Description
Genesys 1 Reagent, REF 01-03-0020 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
Distribution Pattern
IL, WV, NJ, AZ, MD, UT
Code Information
all serial numbers