Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Systems Reagent Cartridges (2013-11-20) — recall 50936

Health Canada — Medical Devices · Canada · 2014-01-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50936
Date of alert
2014-01-06
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens is advising customers of a change in QC values for the Thermo Scientific mas Cardioimmune XL control lot 1601 level 1. The manufacturer of the controls notified siemens of changes to the control product after the QC values were published, and as a consequence, the values provided with the Dimension N-Terminal Pro-Brain Natriuretic Peptide flex reagent lots GA4210, FC4168, FA4098 and FA4224 require revision.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-systems-reagent-cart

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