Urgent Field Safety Notice

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

T Handle Jaws Post Clamp Screw Urgent Field Safety Notice Spinous Process Clamp Tall and Short Model 9734715 and 9734716 Double Spinous Process Clamp Tall and Short Model 9734723

There are three possibilities for impaired performance with the affected ReadyPack: If calibration and sample testing is performed with the same affected ReadyPack, increased

A COLSON ASSOCIATE Page 2 of 3 5885 NE Cornelius Pass Rd Hillsboro, OR 97124 www.acumed.net Both part number COL-3140-S and part number 30-0303-S are sterile packaged screws that

CL2020-126_EU Page 3 of 3 REQUIRED ACTIONS • Review impacted assay list and determine if any modifications to the Qualitative Result Text/Ranges have previously been made to these

CL2015‐072_EU Page 1 of 4 URGENT FIELD SAFETY NOTICE Software Anomaly using enGen™ Laboratory Automation Systems Configured with enGen™ Select v5.0 and Custom or Select v3.2.2

Return Authorisation No _______________ PLEASE PRINT PRODUCT QUANTITY NUMBERS CLEARLY PRODUCT NUMBER LOT NUMBER QUANTITY Returning • Include a copy of the completed

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