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ADVIA 1200 Chemistry System — recall 52969

Health Canada — Medical Devices · Canada · 2014-12-15 · Type III

As described by Health Canada — Medical Devices: ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrator and ADVIA Chemistry System - Liquid Specific Protein (2014-11-06)

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Agency
Health Canada — Medical Devices
Recall identifier
52969
Date of alert
2014-12-15
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 Health Care Diagnostics has confirmed two issues with the Siemens liquid specific protein calibrator lot 303574. Issue 1 : increased frequency of max fit deviation flags using the liquid specific protein (LSP) calibrator kit lot 303574 (vial lots 122IT-127IT) to calibrate the alpha-1-antitrypsin (ATT) assay. The max fit deviation flag impacts the level 2 calibrator (123IT) for the Advia Chemistry Systems AAT assay. Issue 2 : Siemens confirmed that the preliminary version of the Siemens LSP calibrator lot-specific instructions for use (IFU) for calibrator kit lot 303574 resided in the Siemens document library from Dec.10, 2013 until Apr.07, 2014. The LSP calibrator preliminary factor values during this time differed slightly from the final factor values for the following Advia Chemistry System assays: AAG, AAT, ASO_2, C3, C4, FRT, HAPT, IgA_2, IgG_2, IgM_2, PreALB, RF and TRF. The IFU insert packaged in the Siemens LSP calibrator kit lot 303574, always contained the correct values for all those assays, except AAT. The IFU that is currently in the kit and the IFU that was in the Siemens document library from Apr.07, 2014 to Oct.30, 2014 does not reflect the updated AAT calibrator value for LSP calibrator level 2. As of Oct.31, 2014 all of the final LSP calibrator values are correct on the Siemens document library. When using either the final or preliminary calibrator values, quality control results recover well within the manufacturer's specified upper and lower ranges and patient sample results did not demonstrate clinically significant differences.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-1200-chemistry-system-li

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