Official recall record

BD Multitest™ 6-color TBNK (CE/IVD)

Health Canada — Medical Devices · 2024-05-23 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-05-23
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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