BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling 21,455 Access Unconjugated Estriol (uE3) assay systems (Catalog Number 33570) due to alkaline phosphatase (ALP) associated interference that causes falsely elevated test results. The affected systems were distributed worldwide, including across the United States in 33 states and Puerto Rico, as well as in multiple countries including Australia, Canada, China, Germany, India, Mexico, and others. The recalled lot numbers are 921133, 921348, and 921742.
The recall affects healthcare facilities and laboratories using these specific assay systems for estriol testing. The source document does not specify a remedy or recommended action for affected consumers or facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Reason for recall: Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. 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, Quantity: 21455 assay systems Lot/code info: Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.