Product Wiki · Recalls · Health Canada — Medical Devices

BD FACS™ 7-Color Setup Beads — recall 77584

Health Canada — Medical Devices · Canada · 2025-06-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77584
Date of alert
2025-06-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Haematology
Product type
Medical devices
Reported risk: Based on customer complaints, BD has identified errors in the Spectral Overlap Factors (SOF) table provided for specific lots of BD FACS™ 7-color setup beads as listed in the table above. This issue may affect the accuracy of flow cytometry data due to incorrect flow cytometry setup compensation values for multicolor reagents for which proper fluorescence compensation is required prior to analyzing samples. Recall start date: June 3, 2025
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-facstm-7-color-setup-beads

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