Every recall we track for Clark Laboratories, Inc. (dba,Trinity Biotech USA) — 5 in all — plus the complaints and injury reports the public filed about them.
Trinity Biotech USA recalls Genesys Diluent Reagent REF 01-03-0: 510K clearance missing for HPLC use. No specific action steps listed in recall notice.
Trinity Biotech USA recalls Genesys 1 Reagent (REF 01-03-0020) for lack of 510K clearance. This in vitro diagnostic reagent is used with HPLC systems. No specific action is required per recall.
Trinity Biotech USA recalls Genesys Analytical Columns (REF 01-05-001:0017) due to missing 510K documentation for in vitro diagnostics. This affects HPLC systems using ion exchange chromatography.
Trinity Biotech USA recalls Genesys : 510K documentation missing for HPLC reagent. No remedy specified in recall notice.
Trinity Biotech USA recalls Ultra2 Genesys Variants Analyzer (REF 03-01-0045) due to lack of 510K clearance. This device is for in vitro diagnostics and requires regulatory approval before use.
