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ADVIA CHEMISTRY SYSTEMS (2015-09-23) — recall 54508

Health Canada — Medical Devices · Canada · 2015-10-14 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 54508
Date of alert: 2015-10-14
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 Healthcare Diagnostics has confirmed that the Alkaline Phosphatase Reagent Kit lots listed on the report used on the ADVIA 1200, 1650, 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of absorbance flags (u,U) and //// errors. Absorbance flags u and U indicate abnormal high absorbance exceeding either the blank or sample limit. Absorbance flag //// indicates a calculation error and no result is generated by the system.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-chemistry-systems-2015-0

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ADVIA CHEMISTRY SYSTEMS (2015-09-23) — recall 54508

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