Product Wiki · Recalls · Health Canada — Medical Devices

Cobas 8100 BRF System — recall 56772

Health Canada — Medical Devices · Canada · 2017-04-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56772
Date of alert
2017-04-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Following internal investigation of a customer complaint, the manufacturer identified a situation where the Cobas 8100 System Reformatter Module BRF SW Version 02-XX may cause sample racks crash potentially leading to be shaken and specimen to be spilled. There could be an impact on the test performance since a cross-contamination cannot be excluded and could lead to erroneous results. The manufacturer advised us of this on 20-Feb-2017.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-8100-brf-system

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