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U.S. Department of Health and Human Services

Class 2 Device Recall Access Unconjugated Estriol

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  Class 2 Device Recall Access Unconjugated Estriol see related information
Date Initiated by Firm August 26, 2020
Create Date September 24, 2020
Recall Status1 Completed
Recall Number Z-3006-2020
Recall Event ID 86386
Product Classification Radioimmunoassay, estriol - Product Code CGI
Product BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Code Information Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Annette Hellie
714-961-4517
Manufacturer Reason
for Recall		 Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 08/31/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via email and US Post informing them of the potential for an interference with bovine alkaline phosphatase (ALP) in a subset of patient samples tested with the Access Unconjugated Estriol (uE3) assay. Customers are instructed to: - Consider the patients total clinical presentation when interpreting results. - Any retrospective review of patient results is left to the discretion of the Medical Director. - Contact Beckman Coulter Technical Support if you suspect ALP associated interference and do not report the uE3 test result. - Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they have forwarded any of the affected products to another laboratory, to please provide them with a copy of the Customer Notification letter. -Complete and return the enclosed Response Form within 10 days so that the Recalling Firm can be assured that customers have received the important communication. In the meantime, the Recalling Firm is actively working to resolve this issue by end of Q1, 2021. For any questions, please contact the Recalling Firm's Customer Support Center at: - website: http://www.beckmancoulter.com " phone: call 1-800-854-3633 in the United States and Canada. " Outside the United States and Canada contact your local representative.
Quantity in Commerce 21455 assay systems
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
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.
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