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

Recall Z-1394-2023 — AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage 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 t

U.S. FDA — Device Enforcement · Denmark · 2023-03-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1394-2023
Date of alert: 2023-03-08
Country / jurisdiction: Denmark
Risk level: Class II
Risk type: recall
Brand: Radiometer Medical ApS
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05700699335999

Reported risk: Due to potential software issue that may result in patient mix-up information.

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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