medical Class II Updated 2020-09-30

Beckman Coulter Inc. recalls BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjug

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742
View official government recall

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