Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) syst…
- Recall date
- November 1, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0623-2019
- FDA classification
- Class II
- Brand / firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Sold / distributed
- IL, WV, NJ, AZ, MD, UT
Why it was recalled
lack of 510K
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
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