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False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
Low results due to contaminant.
The device has the potential for fractures at the distal end during use.
The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.
Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing.
LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
Seal integrity, sterility not assured.
Product label fails to provide adequate warning for use
improper staple formation or anvil jam
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
Accessory software fails to report certain reports following download of data from 712 pump.