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Recall Observatory FDA recall evidence

Device product

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

Z-1977-2014

June 06, 2014

Class II

Product summary

Firm
BD Biosciences, Systems & Reagents
Event
Event 68490
Status
Terminated
Classification
Class II
Quantity
35 installed devices
Official record key
device-enforcement:Z-1977-2014

Official wording

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

Code information: FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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