Z-1318-06

Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series

Name: Z-1318-06 Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series
Creator: Radiometer America Inc
Published: 2005-06-17
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-06-17 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series on 2005-06-17. The reason FDA records is "Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase". 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-1318-06
Status: Terminated
Initiated: 2005-06-17
Posted: 2006-08-02
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
Root cause tag: software
FDA root cause: Other
Action: The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.
Quantity in commerce: 108 devices
Distribution: Nationwide.
Product codes and lots: All analyzers manufactured from 1/2005-10/31/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.

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)