Exact FDA event identifier

Event 79411

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: February 27, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Radiometer Medical ApS

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

Z-1582-2018

Recall number: Z-1582-2018
Initiated: February 27, 2018
Classification: Class II
Status: Terminated
Recalling firm: Radiometer Medical ApS
Quantity: 2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

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.

Code information

Version 2.3.0 and 2.3.1

Distribution pattern

US Nationwide Distribution in the states to Georgia and Wisconsin.