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Device recall: BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

FDA enforcement event 68490 · Class II · initiated 6 Jun 2014 · status Terminated · terminated 27 Jan 2015

DeviceVoluntary: Firm initiated1 product recordSan Jose, CA

BD Biosciences, Systems & Reagents (San Jose, CA) initiated this device recall on 6 Jun 2014; FDA lists 1 product record under event 68490, 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 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 27 Jan 2015. 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

"Laser cooling fans and internal fan of the associated fluidics cart are not operational."

Distribution

"Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1977-2014	BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.	35 installed devices	Class II	Terminated	9 Jul 2014

Context

91%of 2014 device events are Class II1,176 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
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
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: "Laser cooling fans and internal fan of the associated fluidics cart are not operational."

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: "Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Jan 2015. "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.