Z-0641-2024Class II

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Name: Z-0641-2024 CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2023-10-25
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2023-10-25 / Open, Classified / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of CD11b APC: ASR, REF: 340936, and CE, REF: 333143 on 2023-10-25. FDA classified it as Class II and gives the reason as "In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed...". 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-0641-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-25
Posted: 2024-01-05
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Product code: MVU Reagents, Specific, Analyte
Reason for recall: In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/25/2023, correction notices were mailed and emailed to customers who were asked to do the following: 1) Discard all products subject to the recall following your institution s process for destruction. 2) 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. 3) If lot 3114730 was used, review results and take appropriate action as deemed necessary. 4) Complete and return the response form via email, [email protected] or via Link, https://bdx.my.site.com/CC360/s/impactedproducts?rn=BDB-23-4854 Customers who require further assistance can contact the firm's North American Regional Complaint Center via phone, 1-844-823-5433, say "recall" when prompted Mon-Fri 8:00am and 5:00pm CT, or via email, [email protected]
Quantity in commerce: 464 Vials
Distribution: Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.
Product codes and lots: REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0641-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0641-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)