Product Wiki · Recalls · Health Canada — Medical Devices

Siemens Healthcare Diagnostics Inc. Products — recall 48148

Health Canada — Medical Devices · Canada · 2013-01-07 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
48148
Date of alert
2013-01-07
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The Clinitek Atlas positive control and Chek-Stix positive control for leukocyte reconstituted fails to meet IFU claims. When these lots (mentioned above) of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25º C (77º F).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/siemens-healthcare-diagnostics

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