Product Wiki · Recalls · Health Canada — Medical Devices

Unicel Dxh 800 and 600 Coulter Cellular Analysis System (2017-04-25) — recall 56970

Health Canada — Medical Devices · Canada · 2017-05-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56970
Date of alert
2017-05-16
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: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxh-800-and-600-coulter

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