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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACSCanto Plus

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  Class 2 Device Recall BD FACSCanto Plus see related information
Date Initiated by Firm June 06, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on January 27, 2015
Recall Number Z-1977-2014
Recall Event ID 68490
510(K)Number K141469  
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
Product BD FACS Canto and associated Fluidics Cart

Product Usage: Flow cytometer for use in In vitro Diagnostics.
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.
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Eric R. Claussen
408-954-6307
Manufacturer Reason
for Recall		 Laser cooling fans and internal fan of the associated fluidics cart are not operational.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions.
Quantity in Commerce 35 installed devices
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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