Z-2351-2024Class II

BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD...

Name: Z-2351-2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2024-05-08
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2024-05-08 / Open, Classified / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of 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... on 2024-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2351-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-08
Posted: 2024-07-12
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.
Product code: OYE Flow Cytometric Reagents And Accessories.
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
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected] Recall-related questions can be sent via email to [email protected]
Quantity in commerce: 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
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2351-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2351-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code OYE

K170974Class IIBD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company / cleared 2017-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)