Urgent Field Safety Notice

Recommended confirmation testing for Enterobacteriaceae assay results BioFire BCID Panel Interpretations Recommended Confirmation Testing Enterobacteriaceae Detected Confirm by

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

ADVIA Centaur Affected Product Assay Test Code Catalog Number Siemens Material Number SMN Kit Lots Ending In ADVIA Centaur HIV Ag/Ab Combo CHIV 06520528 10283020 038 and

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

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 Philips Healthcare -3/3- FSN86201571A July 09, 2014 URGENT – Field Safety Notice Expression MR200 MRI Patient

A – January 2015 FIELD CORRECTION EFFECTIVENESS CHECK ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 This response form is to confirm receipt of the enclosed Siemens

The table shows the bias observed in our investigation across the measuring range*: Observed Bias for Serum Samples using VITROS® Na+ Slides, GENs 7-13 Overall Average Mean Bias

Advice on action to be taken by Healthcare Professionals using the BD Vacutainer® EclipseTM SignalTM with Integrated Holder:  Undertake an assessment within your healthcare