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.
lack of 510K
Trinity Biotech USA recalls Genesys Diluent Reagent (REF 01-03-0019) for lacking 510K clearance. This means the product may not meet regulatory safety standards for use with HPLC systems.
The product lacks 510K clearance, which is required for regulatory approval in the U.S. for medical devices. Without this clearance, the reagent may not meet safety standards for in vitro diagnostic use.
Users of the Genesys Diluent Reagent for HPLC systems are affected. Laboratory personnel handling the reagent are most at risk due to potential regulatory non-compliance.
Check for the product name 'Genesys Diluent Reagent' and serial number on the packaging. The reagent is intended for use with automated HPLC systems in labs.
Verify the product name and serial number on the packaging to confirm it matches the recalled item.
The recall states the product lacks 510K clearance, which means it may not meet regulatory safety standards for in vitro diagnostic use.
The recall notice does not specify any action steps for the product.
The recall indicates a lack of regulatory clearance, but no specific hazard mechanism for injury is described.
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-0624-2019 — Trinity Biotech USA Trinity Biotech USA Hello, I own a Trinity Biotech USA that is covered by recall Z-0624-2019 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.
