Product Wiki · Recalls · Health Canada — Medical Devices

Navios Lasers (2013-08-22) — recall 50423

Health Canada — Medical Devices · Canada · 2013-10-25 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50423
Date of alert
2013-10-25
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: Beckman Coulter has determined that the Navios Flow Cytometer instructions for use (IFU) states that when a drip chamber level warning occurs, the instrument will acquire for at least 5 minutes longer after the drip chamber level warning message is displayed. However, the system may only acquire for as little as 3 minutes after the drip chamber level warning and will provide drip chamber level error. At that time, the instrument will abort acquisition and does not save the listmode file, and data are lost.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/navios-lasers-2013-08-22

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