No image published for this recall

No image published for this recall

Bd trucount™ control bead kit, 30 test, ce-ivd

Official notice

18 Jul 2025

Last checked

18 Jul 2025

Medium riskHealth Canada

An official Health Canada notice concerns Bd trucount™ control bead kit, 30 test, ce-ivd. 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 Published 2025-07-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77741

Official notice

2025-07-18

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77741

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Affected products

Product 1

Affected products - Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD, Lot or serial number - 85708, Model or catalog number - 340335

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Becton Dickinson And Bd Biosciences, Bd Trucount™ Control Bead Kit 30 Test Ce-ivd.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77741

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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