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Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) syste
Recalled December 26, 2018 · FDA recall Z-0622-2019 · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
lack of 510K · FDA Class II
Units
252 units
Sold at
IL, WV, NJ, AZ, MD, UT
Description
lack of 510K
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.
Manufacturer(s)
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →