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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80718

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

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Event summary

Timeline bucket
May 25, 2018
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 analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Z-0010-2019
Recall number
Z-0010-2019
Initiated
May 25, 2018
Classification
Class II
Status
Terminated
Recalling firm
Radiometer America Inc
Quantity
12,102

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again

Code information

ABL90 FLEX analyzers with software versions 3.3MR1 or below.

Distribution pattern

US Distribution and Internationally to Canada.