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Premature motor failure.
The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
18 gauge needles in Central Venous Catheter kits may be partially occluded.
A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.
Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
Device was distributed without the dome part accessory, part number 350-DOMPK
Product may have a defective connection.
The compounder may omit an ingredient during the compounding process.