FDA Medical Device Recalls (openFDA)
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 number
- Z-2351-2024
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- 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.
- Status
- Open, Classified
- Initiated
- 2024-05-08
- Posted
- 2024-07-12
- Terminated
- not on file
- Reason
- 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
- Root cause
- Material/Component Contamination
- Action
- 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
- Quantity
- 10,027
- Distribution
- US: MN, NJ, NY, MD, UT, FL, NC, MA, KY, NE, NV, CA, LA, DC, OH, MI, PA, WA, CT, AL, DE, TN, IN, OR, IL, WI, NH, TX, GA, RI, SD, ID, NM, AR. OUS: CA, SG, NZ, AU, KR, IN, PE, GT, AR, MX, TW, CN, NI, CR, JP, BR, TH, BE, VN
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K170974"]
- PMA numbers
- not on file
- Product code
- OYE
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28