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

Recall Z-1582-2018 — AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the p

U.S. FDA — Device Enforcement · Denmark · 2018-02-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1582-2018
Date of alert: 2018-02-27
Country / jurisdiction: Denmark
Risk level: Class II
Risk type: recall
Brand: Radiometer Medical ApS
Product category: device
Product type: Devices

Reported risk: There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.

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

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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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