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.
lack of 510K
Trinity Biotech USA is recalling Genesys Analytical Columns (REF 01-05-0017) because they lack required 510K documentation for in vitro diagnostic use. This means the product may not meet regulatory safety standards, but it does not pose an immediate physical hazard.
The recall is due to the absence of a 510K (a regulatory submission for medical devices) for the Genesys Analytical Column. This means the product may not meet FDA safety standards for in vitro diagnostics, but it does not cause physical harm during normal use.
Users of Genesys Analytical Columns for in vitro diagnostic testing with HPLC systems are affected. Laboratory personnel and healthcare providers using these columns for ion exchange chromatography are most at risk.
Check for the Genesys Analytical Column with reference number 01-05-0017. These columns are used with automated high performance liquid chromatography systems for in vitro diagnostic testing.
Verify if the column has a 510K regulatory submission document for in vitro diagnostic use.
No, the recall is due to missing regulatory documentation, not an immediate physical hazard.
The official notice does not specify a remedy, so check with the manufacturer for guidance.
The recalled product is the Genesys Analytical Column with reference number 01-05-0017 used in HPLC systems for in vitro diagnostics.
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-0621-2019 — Trinity Biotech USA Trinity Biotech USA Hello, I own a Trinity Biotech USA that is covered by recall Z-0621-2019 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.
