IMPORTANT NOTIFICATION
Contents
1. Ortho Clinical Diagnostics xx May 2015 URGENT SAFETY FIELD NOTICE Accessing Samples on ORTHO VISION Analyzer for ORTHO BioVue Cassettes using Software Version 1 0 4 Product Code 6904579 Dear Valued Customer As part of a Field Safety Corrective Action this is to inform you of an Urgent Field Safety Notice involving the following product Affected System Affected Software Version Product Code ORTHO VISION Analyzer for ORTHO BioVue Cassettes 1 0 4 6904579 Issue Explanation The ORTHO VISION Analyzer Reference Guide ISS655ENx dated 2014 09 02 Section 9 Manual sample registration Assign position instructs users to access samples using the Sample Rack load unload screen wizard not the Dilution Rack screen load unload screen wizard in order to identify the sample and update the sample s order Ortho Clinical Diagnostics Inc OCD has identified that when the instructions noted above are not followed the potential of erroneous results exists In order for this anomaly to occur all of the following sequence of events must be met 1 A user accesses a Sample Rack using the Dilution Rack load unload screen wizard 2 The Sample Rack contains a sample with a manually assigned bar code 3 The user exchanges the sample with a manually assigned barcoded sample ID with a different sample Impact to Results When the analyzer is used in accordance with the ORTHO VISION Analyzer Reference Gui2. de J55655ENx Section 9 instructions there is no impact to results If the instructions noted are not followed processing of a sample with a mismatched sample ID may occur and the potential for erroneous results to be generated and reported exists This occurs because the ORTHO VISION unexpectedly does not recognize the sequence of events above To date no customer complaints or patient injury due to this issue have been reported to OCD Actions Required To prevent the potential for erroneous results follow Section 9 of the ORTHO VISION Analyzer Reference Guide to access samples from the Sample Rack load unload screen wizard only Complete and return the Confirmation of Receipt form no later than xx May 2015 Post this notification by each ORTHO VISION Analyzer in your facility or with the user documentation Please contact an Ortho Clinical Diagnostics representative if you experience this anomaly Ref CL2015 097_EU Page 1 of 2 URGENT FIELD SAFETY NOTICE Accessing Samples on ORTHO VISION Analyzer for ORTHO BioVue Cassettes using Software Version 1 0 4 Resolution ORTHO VISION software will be updated in the future so that manually assigned Sample IDs will be cleared when a sample is accessed by the user from the Dilution Rack load unload screen wizard We apologize for the inconvenience this may cause your laboratory If you have any additional questions please contact Customer Technical Services at Since
3. rely Ref CL2015 097_EU Page 2 of 2 URGENT FIELD SAFETY NOTICE Accessing Samples on ORTHO VISION Analyzer for ORTHO BioVue Cassettes using Software Version 1 0 4
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