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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83312

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

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Event summary

Timeline bucket
July 10, 2019
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

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Z-2320-2019
Recall number
Z-2320-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Radiometer America Inc
Quantity
13,042 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software security vulnerabilities with the firm's analyzer operating system, which may cause

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

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

Code information

All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX

Distribution pattern

US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico