BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results

Plain-English summary

BD Multitest 6-Color TBNK is a flow cytometry reagent made by Becton Dickinson and Company (BD Biosciences) used to measure immune system cells in patient blood samples. The product is sold under several product codes in configurations for clinical laboratory use.

The recalled product contains contaminated antibodies from compromised raw materials. The contamination may cause flow cytometry test results to show incorrect cell population counts, unusual staining patterns, and high background noise. These technical problems may lead to inaccurate or delayed test results that could affect patient care decisions.

Approximately 10,027 units were distributed to healthcare facilities in 34 U.S. states, Washington DC, and multiple international countries. Affected laboratories should contact BD Biosciences to confirm whether their inventory contains recalled lot numbers and to follow the manufacturer's recommendations for addressing potentially affected patient test results.

The recalled product

Product

BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent wit

Manufacturer

Becton, Dickinson and Company, BD Biosciences

Category

Medical Device — Flow Cytometry Reagent

Hazard

• contaminated-antibodies
• erroneous-results
• diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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