Recall Monitor
Health Products

Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD85708340335

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

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