Duraclone B27 Reagent Kit
Last updated
Summary
Product
Duraclone B27 Reagent Kit
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Duraclone B27 Reagent Kit |
More than 10 numbers, contact manufacturer. |
B36862 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
Beckman Coulter India Private Limited
50b, Ii Phase, (Near Tvs Cross), Bangalore, Karnataka, India, 560058
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64235
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