Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0620-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0620-2019
Date of alert
2018-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Product category
device
Product type
Devices
Reported risk: lack of 510K
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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