—#183566

Product

BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

FDA product code: CGI — Radioimmunoassay, Estriol
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742

Why it was recalled

Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-08-26
Terminated: 2024-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183566. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.