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Duraclone B27 Reagent Kit — recall 64235

Health Canada — Medical Devices · Canada · 2022-06-07 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 64235
Date of alert: 2022-06-07
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Beckman coulter has discovered that affected Duraclone B27 Reagent Kits may exhibit reduced fluorescence intensity potentially leading to incorrect results. Consequently, Duraclone B27 may not conform to sensitivity and accuracy claim of 100% and 95% respectively as outlined in the product instructions for use (IFU). Recall start date: May 23, 2022

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/duraclone-b27-reagent-kit

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Duraclone B27 Reagent Kit — recall 64235

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