Recalling Firm / Manufacturer

Sendx Medical Inc.

Product

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

Code Information

Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.

Reason of 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 error

Date Recall Initiated

June 04, 2007

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. Firm Initiated recall is ongoing.

Contact

N/A

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.