Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista System - MMB Calibrator (2014-08-18) — recall 52333

Health Canada — Medical Devices · Canada · 2014-08-25 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52333
Date of alert
2014-08-25
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 determined that Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB Cal) shows drift during routine stability monitoring that exceeds the acceptance criteria for drift over the shelf life of this product (12 months). Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been detected. Due to the drift, Siemens is revising the expiration date of this product (to 6 months). Siemens is issuing an urgent field safety notice letter for the aforementioned lots of Dimension Vista MMB Cal.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-mmb-cal

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