FDAFDA · Food and drugs·Recall number Z-1977-2014
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Published July 9, 2014 · Recall initiated: June 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Laser cooling fans and internal fan of the associated fluidics cart are not operational.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BD Biosciences, Systems & Reagents
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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