Food, drugs, devices › BD Biosciences, Systems & Reagents

Device recall: CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

FDA enforcement event 70811 · Class II · initiated 23 Mar 2015 · status Terminated · terminated 26 Feb 2016

DeviceVoluntary: Firm initiated1 product recordSan Jose, CA

BD Biosciences, Systems & Reagents (San Jose, CA) initiated this device recall on 23 Mar 2015; FDA lists 1 product record under event 70811, classified Class II.

FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 26 Feb 2016. Initiation: voluntary: firm initiated. BD Biosciences, Systems & Reagents has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

BD Biosciences, Systems & Reagents, San Jose, CA.

Reason for recall

"One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern."

Distribution

"US Distribution in states of: MO, GA, AZ, NE, TX, VA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1375-2015	CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent	9	Class II	Terminated	8 Apr 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for 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
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
4 Apr 2014	Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has bee	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

All 9 events for BD Biosciences, Systems & Reagents

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution in states of: MO, GA, AZ, NE, TX, VA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.