Recall Z-2351-2024
Becton, Dickinson and Company, BD Biosciences · initiated May 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
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
FDA-determined cause: Material/Component Contamination
Action taken
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
Details
- Recall number
- Z-2351-2024
- Initiated
- May 8, 2024
- Posted by FDA
- July 12, 2024
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- 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
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences, San Jose, CA