medical Class II Updated 2018-12-26

Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys 1 Reagent, REF 01-03-0020 intended to be used with a

Recalled 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.


Hazard / Issue

lack of 510K

Issued by

FDA

Affected States: IL, WV, NJ, AZ, MD, UT
Lot/Code Info: all serial numbers
View official government recall

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