Z-1325-06

ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21

Name: Z-1325-06 ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21
Creator: Radiometer America Inc
Published: 2005-10-31
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-10-31 / Terminated

FDA source

Radiometer America Inc began a recall of ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21 on 2005-10-31. The reason FDA records is "ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1325-06
Status: Terminated
Initiated: 2005-10-31
Posted: 2006-08-03
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
FDA root cause: Other
Action: The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
Quantity in commerce: 36
Distribution: Worldwide, including USA and Canada.
Product codes and lots: All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)