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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84496

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

Open FDA event record

Event summary

Timeline bucket
August 08, 2019
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 basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

Z-0864-2020
Recall number
Z-0864-2020
Initiated
August 08, 2019
Classification
Class II
Status
Terminated
Recalling firm
Radiometer Medical ApS
Quantity
947

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

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

The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

Code information

Software version 2.3.5 and below

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of:  Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Field note

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