Recall Z-0622-2019— Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Class II · Terminated
Class II FDA medical device recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), initiated 2018-11-01, terminated 2022-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: lack of 510K.
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-01
- Terminated
- 2022-06-21
- Firm location
- Jamestown, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.