Health product recall

BD Multitest™ 6-color TBNK (CE/IVD)

Last updated

Summary

Product
BD Multitest™ 6-color TBNK (CE/IVD)
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

BD Multitest™ 6-color TBNK (CE/IVD)

49510
32674

644611

Issue

BD observed an increasing trend of complaints for unusual staining pattern, nonspecific aggregates, high background, double positive signal, and/or antibodies contaminated with substance for the affected catalog. The investigation detected a damaged component in affected product catalog may affect integrity of stained cells, causing increase in cell debris (i.e. background) as shown on SSC VS CD45 positive leukocyte flow cytometry plots, resulting in atypical increase of double positive events on CD3+CD4+ vs CD3+CD8+ and/or CD3-CD16+CD56+ vs CD3-CD19+ plots.

Recall start date: May 8, 2024

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-75554

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