Recall Z-2258-2021— Beckman Coulter Inc.

Name: FDA recall Z-2258-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-07-01, terminated 2023-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017. Reason: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis ..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Terminated: 2023-06-14
Firm location: Brea, CA, United States

Product description

ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

Reason for recall

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

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