Product Wiki · Recalls · Health Canada — Medical Devices

Cobas 6500 U601 Urinalys system-Urine Analyzer and Cobas U701… — recall 58199

Health Canada — Medical Devices · Canada · 2018-08-17 · Type III

As described by Health Canada — Medical Devices: Cobas 6500 U601 Urinalys system-Urine Analyzer and Cobas U701 Microscopy Analyzer (2018-07-19)

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Agency
Health Canada — Medical Devices
Recall identifier
58199
Date of alert
2018-08-17
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The manufacturer confirmed that when working in barcode mode during processing of sample measurements on Cobas u601 and Cobas u701 analyzers, a possible sample mismatch may occur in very rare circumstances when the instructions are not followed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-6500-u601-urinalys-syste

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