Product Wiki · Recalls · Health Canada — Medical Devices

AQUIOS CL FLOW CYTOMETRY SYSTEM (2017-10-02) — recall 57889

Health Canada — Medical Devices · Canada · 2017-11-28 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
57889
Date of alert
2017-11-28
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: When AQUIOS CL Systems are connected to a Laboratory Information System (LIS), the system may duplicate sample requests leading to sample mis-identification. For this to happen, the following conditions must be met: The AQUIOS CL Flow Cytometer is connected to an LIS and The AQUIOS CL System has the default test enabled and Host query is enabled in LIS setup screen on system and There are multiple cassettes in the autoloader and The LIS host query response is received in a brief time window before LIS response timeout occurs. When all of these conditions are met, a sample will follow two (2) paths of test request creation (LIS and Default Test). All software versions (2.0, 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the AQUIOS CL are impacted by this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aquios-cl-flow-cytometry-syste

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