Becton, Dickinson and Company, BD Biosciences 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 with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.
Brand
Becton, Dickinson and Company, BD Biosciences
Lot Codes / Batch Numbers
REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24, 337166/382903371662/17569-31-Jul-24, 22709-31-Aug-24, 49517-30-Sep-24, 662967/382906629678/17572-31-Jul-24, 17582-31-Jul-24, 26797-31-Aug-24, 69761-30-Sep-24, 49506-30-Sep-24, 662995/382906629951/49508-30-Sep-24
Products Sold
REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24; 337166/382903371662/17569-31-Jul-24, 22709-31-Aug-24, 49517-30-Sep-24; 662967/382906629678/17572-31-Jul-24, 17582-31-Jul-24, 26797-31-Aug-24, 69761-30-Sep-24, 49506-30-Sep-24; 662995/382906629951/49508-30-Sep-24
Becton, Dickinson and Company, BD Biosciences is recalling BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes due to Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecif. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions
Recommended Action
Per FDA guidance
On 5/8/24, correction notices were sent to Lab Managers and Risk Managers asking them to do the following: 1) Discuss the content of this letter with your laboratory management regarding the need to review previous test results associated with these affected lots. 2) Discard all products subject to the recall following your institution s process for destruction. 3) Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4) Complete and return the response form via email to BDRC13@bd.com or fill out the form using this link: https://bdx.my.site.com/CC360/s/impactedproducts?rn=BDB-24-5033 If you require further assistance contact the firm's North American Reginal Complaint Center via phone 1-844-823-5433 Say "Complaints" when prompted Mon Fri 8:00am and 5:00pm CT or via email productcomplaints@bd.com Recall-related questions can be sent via email to BDRC13@bd.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CT, DE, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SD, TN, TX, UT, WA, WI, DC
Page updated: Jan 10, 2026