FDANovember 1, 2018device
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
lack of 510K
What to do
FDA enforcement status: Terminated
Brands named
clark laboratories inc dba trinity biotech usaclarkclark laboratories
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
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