URGENT FIELD SAFETY NOTICE - HPRA

Urgent Field Safety Notice 4006 June 2013 PSA Assays for the Following Systems: IMMULITE® IMMULITE® 1000 IMMULITE® 2000 IMMULITE® 2000 XPi PSA Positive Bias to WHO 96/670

Patient Median Bias Compared to the IGF-I IFU Reference Range Medians IMMULITE 2000/2000 XPi IGF-I Kit Lots Median Performance Compared to IGF-I IFU Reference Range Medians 469

Avenue de Sévelin 46 CH - 1004 Lausanne, Switzerland March 25, 2017 URGENT FIELD SAFETY NOTICE - DEVICE RECALL NOTIFICATION Affected product: CT Exprès Contrast Injection System,

Actions: If your surgical procedure involves the use of the Medtronic DBS depth stop, Medtronic recommends the following:  For implanted product: If product has already been

If the display shows the cylinder pressure does not correspond to the open cylinder, and if you choose to continue to use your anesthesia system, ensure the following: a.. Your

If, after you replace the empty Wash 1 bottle, the Supplies Status button continues to display yellow, or if there was already sufficient Wash 1 in the bottle, perform the following

Required Actions  An Ortho-trained service representative will contact you to schedule the inspection of the wiring configuring within the VITROS® 5600 Systems at your facility.. If

14 Printing of results for Replicates The printed reports for Lab Results by Sample and Lab Results by Test do not print replicate data in the same order as displayed on the Test