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Advia and Advia 1200 Chemistry System — recall 50114

Health Canada — Medical Devices · Canada · 2013-10-31 · Type II

As described by Health Canada — Medical Devices: Advia and Advia 1200 Chemistry System - Chemistry Calibrators (2013-09-30)

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Agency
Health Canada — Medical Devices
Recall identifier
50114
Date of alert
2013-10-31
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Quality control (QC) is shifting higher impacting Direct Bilirubin (DBIL_2) with Siemens Chemistry Calibrator lots 090445B and 090445C from previous lots 090445 and 090445A. Observed QC shifts are approx. 7-9% higher with calibrator lots 090445B and 090445C. An urgent field safety notice has been issued by the manufacturer to provide affected customers with reassigned system specific values for the DBIL_2 SSVS for Chemistry Calibrator lot numbers 090445B and 090445C. Manufacturer has determined that the DBIL_2 ssvs currently assigned to these lots may cause an average shift of plus 7-9% in quality control and sample recovery at a level of 3 mg/dL. The urgent field safety notice provides reassigned values for the DBIL_2 ssvs for Chemistry Calibrator lot numbers 090445B and 090445C.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-and-advia-1200-chemistry

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