The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
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Diagnostic Equipment
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The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class I - Dangerous
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.