Z-1095-2007

ABL 800 FLEX series blood gas analyzers containing software version 5.24

Name: Z-1095-2007 ABL 800 FLEX series blood gas analyzers containing software version 5.24
Creator: Radiometer America Inc
Published: 2006-11-13
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-11-13 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL 800 FLEX series blood gas analyzers containing software version 5.24 on 2006-11-13. The reason FDA records is "Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1095-2007
Status: Terminated
Initiated: 2006-11-13
Posted: 2007-07-24
Terminated: 2012-05-09
Recalling firm: Radiometer America, Inc
Product: ABL 800 FLEX series blood gas analyzers containing software version 5.24.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem
Root cause tag: software
FDA root cause: Software design
Action: The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will be coming out and making a software upgrade to these systems within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and completed by each customer in order to verify that the alert notification has been received and that the staff members responsible for operating and maintaining the analyzer(s) on-site have been informed of this situation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Removal, and Decontamination programs have been made.
Quantity in commerce: 464
Distribution: The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada.
Product codes and lots: ABL 800 FLEX series blood gas analyzers containing software version 5.24.

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)