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All product recalls associated with Sendx Medical Inc.
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Feb 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the
Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.
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