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.
lack of 510K
Trinity Biotech USA is recalling Genesys 1 Reagent (REF 01-03-0020) because it lacks 510K clearance. This means the product hasn't been properly approved for use in diagnostic testing. The recall does not require immediate action.
The lack of 510K clearance means the product has not been approved by the FDA for in vitro diagnostic use. This could lead to inaccurate test results or potential health risks if used improperly. However, the specific health risks are not detailed in the recall notice.
Users of this reagent for in vitro diagnostic testing with HPLC systems are affected. Laboratory personnel handling the reagent may be at risk if the product is used without proper regulatory approval.
Check for the product name 'Genesys 1 Reagent' and serial number on the packaging. This reagent is intended for use with automated HPLC systems in diagnostic testing.
Review the product label for the serial number and ensure it matches the recalled item.
The recall states a lack of 510K clearance, but does not specify any injury risks.
The recall does not require stopping use; no specific action is required per the notice.
Look for the product name 'Genesys 1 Reagent' and the serial number on the packaging.
We’ve drafted a message you can send Trinity Biotech USA to request your refund or repair — edit it as you like.
Subject: Recall Z-0622-2019 — Trinity Biotech USA Trinity Biotech USA Hello, I own a Trinity Biotech USA that is covered by recall Z-0622-2019 from Trinity Biotech USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
