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Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatograp
Recalled December 26, 2018 · FDA recall Z-0620-2019 · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
lack of 510K · FDA Class II
Units
14 devices
Sold at
IL, WV, NJ, AZ, MD, UT
Description
lack of 510K
Product
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Manufacturer(s)
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →