Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81547

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

Open FDA event record

Event summary

Timeline bucket
July 03, 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

ABL800 analyzer, model numbers 393-800 and 393-801.

Z-0682-2019
Recall number
Z-0682-2019
Initiated
July 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Radiometer America Inc
Quantity
2,131 analyzers

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software 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

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

Code information

Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

Distribution pattern

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.