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

Recall Z-2764-2019 — Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotome

U.S. FDA — Device Enforcement · Netherlands · 2016-07-12 · Class III

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2764-2019
Date of alert: 2016-07-12
Country / jurisdiction: Netherlands
Risk level: Class III
Risk type: recall
Brand: ELITech Group B.V.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03661540600357

Reported risk: Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related