Recall Z-3006-2020— Beckman Coulter Inc.

Name: FDA recall Z-3006-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-26

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2020-08-26, terminated 2024-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.. Reason: Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Terminated: 2024-05-24
Firm location: Brea, CA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.