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During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.
The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.