Recall Z-0621-2019— Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Name: FDA recall Z-0621-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-01

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 Analytical Column, REF 01-05-0017 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 Analytical Column, REF 01-05-0017 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.