Trinity Biotech USA recalls Genesys : 510K documentation missing for HPLC reagent. No remedy specified in recall notice.
lack of 510K
Trinity Biotech USA is recalling Genesys 2 Reagent (REF 01-03-0022) due to missing 510K documentation. This reagent is for use with HPLC systems and is intended for in vitro diagnostics. The recall does not include a remedy or action for consumers.
The recall mentions a 'lack of 510K', which refers to missing regulatory documentation required for medical devices in the U.S. This could mean the product hasn't been properly approved for use, but the exact risk isn't specified in the notice.
Users of the Genesys 2 Reagent for HPLC systems are affected. The risk is unclear without specific safety details.
Check for the Genesys 2 Reagent with serial numbers. The product is intended for use with automated high performance liquid chromatography (HPLC) systems in in vitro diagnostic applications.
Verify if the reagent has a 510K regulatory document, as the recall indicates this is missing.
The recall states there is a lack of 510K documentation, which is regulatory paperwork required for medical devices in the U.S. The exact risk isn't specified in the notice.
The recall does not specify a remedy or action, so there is no instruction to stop using the product.
The recall notice does not mention any remedy or replacement options.
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-0623-2019 — Trinity Biotech USA Trinity Biotech USA Hello, I own a Trinity Biotech USA that is covered by recall Z-0623-2019 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.
