ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
FDA Recall Z-1201-2007 · Posted 2007-08-29
Recalling FirmSendx Medical Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2007-06-04
Date Terminated2012-02-29
Product Quantity165 software upgrade CDs
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
Firm 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.
Root Cause
Other
Distribution Pattern
In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.