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.
lack of 510K
Trinity Biotech USA is recalling their Ultra2 Genesys Variants Analyzer (REF 03-01-0045) because it lacks 510K regulatory clearance. This means the device may not be safe for in vitro diagnostic use without proper regulatory approval.
The device lacks 510K clearance, which is a regulatory approval required for medical devices in the U.S. This means it may not meet safety standards for in vitro diagnostic use, potentially leading to unsafe results or device failure.
Users of this in vitro diagnostic device for high performance liquid chromatography systems. Those who have the specific model with serial numbers are most at risk.
Check if you have the Ultra2 Genesys Variants Analyzer with serial number REF 03-01-0045. This device is intended for use with automated high performance liquid chromatography systems.
Identify the serial number on your Ultra2 Genesys Variants Analyzer to confirm if it is the recalled model REF 03-01-0045.
The recall states the device lacks 510K clearance, meaning it may not be safe for in vitro diagnostic use without proper regulatory approval.
The recall does not specify a remedy, so you should check the serial number and contact the manufacturer if you have concerns.
The recall does not describe specific injury risks, only that the device lacks regulatory clearance.
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-0620-2019 — Trinity Biotech USA Trinity Biotech USA Hello, I own a Trinity Biotech USA that is covered by recall Z-0620-2019 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.
