Urgent Field Safety Notice - ncmdr

Mailing Number 13-99 GPF-003-6 V4.0 Effective: 2012-03-09 FIELD CORRECTION EFFECTIVENESS CHECK Potential Sampling Issue with Radiometer Blood Gas Analyzers This response form is to

Two separate issues have been identified:  VITROS Na+ Slides, GENs 8 & 13: Positively biased urine sample results  VITROS Na+ Slides, GENs 13, 14, 16, 17 & 18: Positively biased

Any product remaining in the field will be returned to the manufacturer as part of this field safety corrective action and therefore will be not at risk of being implanted.. Increased

A GPF-003 -11 V2.0 Effective: 2013-03-25 Related Procedure: GP-003 DX- Field Correction Action FIELD CORRECTION EFFECTIVENESS CHECK Disabled Test in CentraLink System or Aptio

ADVIA Centaur Affected Products Product Siemens Material Number SMN Bulk Fluid Reserve Assembly Acid & Base 10282187 10483525 Wash 1 Reservoir Connector 10364516 10483526 Reason

xx May 2015 URGENT FIELD SAFETY NOTICE Software Anomaly Affecting User Defined Protocol Feature on ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes Dear Valued Customer, As

Box 262 1274 Signy-Centre, Suisse Tel: +41.22.363.9011 www.haemonetics.com RCL-100298-IEAA Page 2 of 3 FSCA-FY20-03 making any decisions, the attendant physician must

Statistical analysis indicates that with increasing operation time of the HU 35, the probability of leakage within its expected service life of 10 years increases due to material