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Health Canada Medical devices

Duraclone B27 Reagent Kit

Issued June 7, 2022
Issue
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
Hazard description
Performance
Product
Product name
Duraclone B27 Reagent Kit
Reference
ID
RA-64235