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U.S. Department of Health and Human Services

Class 2 Device Recall Access BR Monitor

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  Class 2 Device Recall Access BR Monitor see related information
Date Initiated by Firm April 13, 2017
Create Date May 12, 2017
Recall Status1 Terminated 3 on June 04, 2018
Recall Number Z-2074-2017
Recall Event ID 77029
510(K)Number K033036  K072612  
Product Classification System, test, immunological, antigen, tumor - Product Code MOI
Product Access BR Monitor, Part No. 387620
Code Information 623913, 625701, 628771, 630349, 633070 and All Future Lots
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
FDA Determined
Cause 2
Other
Action An urgent Medical Device Recall letter dated 4/13/17 was sent to customers following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU). Customers are informed of the impact and the actions to be taken. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 1-800-854-3633 in the United States and Canada. ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in Commerce 45,278 units total (2,419 units in US)
Distribution Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe
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.
510(K) Database 510(K)s with Product Code = MOI and Original Applicant = BECKMAN COULTER, INC.
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