Z-1201-2007

ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863

Name: Z-1201-2007 ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
Creator: Sendx Medical Inc
Published: 2007-06-04
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2007-06-04 / Terminated / root cause: software

FDA source

Sendx Medical Inc began a recall of ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 on 2007-06-04. The reason FDA records is "The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value...". 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-1201-2007
Status: Terminated
Initiated: 2007-06-04
Posted: 2007-08-29
Terminated: 2012-02-29
Recalling firm: Sendx Medical, Inc.
Product: ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err
Root cause tag: software
FDA root cause: Other
Action: A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.
Quantity in commerce: 165 software upgrade CDs
Distribution: In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
Product codes and lots: Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.

Product code CHL

K051804Class IIAbl80 Flex AnalyzerSendx Medical, Inc. / cleared 2005-11-01

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)