FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
- Recall number
- Z-3006-2020
- Recalling firm
- Beckman Coulter Inc.
- Product
- BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
- Status
- Terminated
- Initiated
- 2020-08-26
- Posted
- not on file
- Terminated
- 2024-05-24
- Reason
- Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CGI
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28