Product Wiki · Recalls · Health Canada — Medical Devices

Advia Chemistry Systems (2013-11-11) — recall 50375

Health Canada — Medical Devices · Canada · 2013-12-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50375
Date of alert
2013-12-04
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: Siemens confirms that three issues were identified where the system may pass calibration and QC, when it should not. These include auto-calibration with flagged system related errors, auto-calibration with a lot change and reagent pack switching mid-calibration or mid-QC. Users are being advised when any of the three situations occur, to perform the calibration or QC again.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-chemistry-systems-2013-1

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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