Device recall: Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has…

Class II FDA enforcement event 67948. Recall start date: 4 Apr 2014. Status in the FDA record: Terminated. Termination date: 28 Sep 2015.

Reason for recall, in the words of FDA

Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.

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

BD Biosciences, Systems & Reagents started this device recall on 4 Apr 2014. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 67948 has 1 product record. The first FDA enforcement report date is 7 May 2014. The record gives the status Terminated, with the termination date 28 Sep 2015.

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 Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.

Recalling firm

BD Biosciences, Systems & Reagents, 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 67948: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1536-2014	Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.	12 for lot 3295974; 10 of lot 3259822	Class II	Terminated	7 May 2014

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 2014: 1,176
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: 9

Other events of the firm

Other FDA enforcement events of BD Biosciences, Systems & Reagents
Initiated	Product (first record)	Type	Class	Records
15 Jun 2015	BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,B	Device	Class III	1
23 Mar 2015	CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent	Device	Class II	1
6 Mar 2015	BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.	Device	Class II	1
19 Dec 2014	Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hem	Device	Class II	1
19 Dec 2014	CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent	Device	Class II	1
18 Jul 2014	BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flo	Device	Class III	1
6 Jun 2014	BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.	Device	Class II	1
29 Jun 2012	BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic	Device	Class II	1

BD Biosciences, Systems & Reagents: all 9 events

Official channels

FDA enforcement report Z-1536-2014The 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 67948. https://recallregister.com/fda/ii/67948/. 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 Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
What quantity of product is in FDA event 67948?: The FDA record gives this quantity: 12 for lot 3295974; 10 of lot 3259822
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.