Exact FDA event identifier

Event 75836

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

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Event summary

Timeline bucket: November 23, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Radiometer America Inc

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 System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: 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 the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you 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-0899-2017

Recall number: Z-0899-2017
Initiated: November 23, 2016
Classification: Class II
Status: Terminated
Recalling firm: Radiometer America Inc
Quantity: 7 total (2 in US)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Design error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

Code information

UDI: (01)05700699335999(10)2.2.0

Distribution pattern

Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.