Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD
Last updated
Summary
Product
Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD
Issue
Medical devices - Performance
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 |
|---|---|---|
| Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD | 85708 | 340335 |
Issue
BD has observed an increasing trend in complaints related to the BD Trucount™ Controls Kit, specifically due to incorrect standard deviation (SD) values for the low and high control beads on the labeling of the kit, which compromises the accurate calculation of bead counts.
Recall start date: July 8, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Becton, Dickinson And Company Bd Biosciences
155 North Mccarthy Boulevard, Milpitas, California, United States, 95035
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77741
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