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U.S. Department of Health and Human Services

Class 2 Device Recall Access SystemGI Monitor

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  Class 2 Device Recall Access SystemGI Monitor see related information
Date Initiated by Firm May 09, 2017
Create Date June 28, 2017
Recall Status1 Terminated 3 on March 30, 2018
Recall Number Z-2638-2017
Recall Event ID 77245
510(K)Number K033038  
Product Classification System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
Product Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Code Information all lots
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
The Access immunoassays are susceptible to biotin interference.
FDA Determined
Cause 2
Device Design
Action An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. Customers are informed of the impact, action, and resolution. Customers are instructed to respond within 10 days: electronically via email or manually by completing and returning the enclosed response form. 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 249,597 units total (9,388 units in US)
Distribution Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, 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 = NIG and Original Applicant = BECKMAN COULTER, INC.