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

Class II FDA enforcement event 93569. Recall start date: 25 Oct 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Becton, Dickinson and Company, BD Biosciences started this device recall on 25 Oct 2023. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 93569 has 1 product record. The first FDA enforcement report date is 17 Jan 2024. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

Becton, Dickinson and Company, BD Biosciences, San Jose, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 93569: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0641-2024	CD11b APC: ASR, REF: 340936, and CE, REF: 333143	464 Vials	Class II	Ongoing	17 Jan 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 22

Other events of the firm

Other FDA enforcement events of Becton, Dickinson and Company, BD Biosciences
Initiated	Product (first record)	Type	Class	Records
8 May 2024	BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;	Device	Class II	1
3 Oct 2022	BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are	Device	Class II	3
25 Mar 2022	BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recog	Device	Class II	2
22 Jul 2021	BD" Mouse IgG2a Isotype Control APC X39 ASR	Device	Class II	1
5 Oct 2020	BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping	Device	Class II	1
31 Mar 2020	Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (	Device	Class II	1
19 Aug 2019	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes	Device	Class II	9
8 Jul 2019	BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical soft	Device	Class II	3
2 Jan 2019	BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flo	Device	Class III	1
16 May 2018	BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The f	Device	Class III	1

Becton, Dickinson and Company, BD Biosciences: all 22 events

Official channels

FDA enforcement report Z-0641-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 93569. https://recallregister.com/fda/ii/93569/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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,…
What quantity of product is in FDA event 93569?: The FDA record gives this quantity: 464 Vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.