Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA 120, 21201 and 2120 Hematology System (2020-03-06) — recall 63296

Health Canada — Medical Devices · Canada · 2020-04-16 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
63296
Date of alert
2020-04-16
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics Inc. has confirmed that certain lots of ADVIA 120/2120/2120I CBC TIMEPACS and CN-FREE CBC TIMEPACS may exhibit an elevated % baso count, which may lead to unnecessary flagging and manual slide review. Whenever such flags are triggered, the user should review the results and take the action recommended. Siemens has confirmed that certain lots of baso reagent contained within the timepacs may cause a shift of at least 1.5 times higher than expected for % baso.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-120-21201-and-2120-hemat

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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