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Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC)
Recalled December 26, 2018 · FDA recall Z-0624-2019 · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
lack of 510K · FDA Class II
Units
463 units
Sold at
IL, WV, NJ, AZ, MD, UT
Description
lack of 510K
Product
Genesys Diluent Reagent, REF 01-03-0019 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 →