Device recall: BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes…

Class II FDA enforcement event 71826. Recall start date: 17 Jul 2015. Status in the FDA record: Terminated. Termination date: 11 Mar 2016.

Reason for recall, in the words of FDA

Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.

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 17 Jul 2015. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 71826 has 1 product record. The first FDA enforcement report date is 2 Sep 2015. The record gives the status Terminated, with the termination date 11 Mar 2016.

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.

US Distribution and Internationally to Taiwan.

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 71826: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2453-2015	BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.	362 units	Class II	Terminated	2 Sep 2015

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 2015: 1,153
Share of these events in Class II: 91%
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
25 Oct 2023	CD11b APC: ASR, REF: 340936, and CE, REF: 333143	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

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

Official channels

FDA enforcement report Z-2453-2015The 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.

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Cite this page

Recall Register. FDA enforcement event 71826. https://recallregister.com/fda/ii/71826/. 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: US Distribution and Internationally to Taiwan.
What quantity of product is in FDA event 71826?: The FDA record gives this quantity: 362 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.