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

Recall Z-2558-2019 — V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monito

U.S. FDA — Device Enforcement · Netherlands · 2016-01-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2558-2019
Date of alert: 2016-01-18
Country / jurisdiction: Netherlands
Risk level: Class II
Risk type: recall
Brand: Vital Scientific N.V.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03661540600180

Reported risk: Instrument stopped working due to a software lockup, and no patient results are produced.

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.

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