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.
This recall has been terminated (originally issued November 1, 2018).
- Recall Initiated
- November 1, 2018
- Terminated
- June 21, 2022
- Recall Number
- Z-0622-2019
- Quantity
- 252 units
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
lack of 510K
Distribution
IL, WV, NJ, AZ, MD, UT
Lot / Code Info
all serial numbers
Root Cause
No Marketing Application
Action Taken
The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
More recalls by Clark Laboratories, Inc. (Dba, Trinity Biotech Usa)
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance...
Nov 1, 2018
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid c...
Nov 1, 2018
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromat...
Nov 1, 2018