Home / Recalls / Medical Devices
Beckman Coulter Inc. recalls ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743
Recalled August 18, 2021 · FDA recall Z-2258-2021 · Beckman Coulter
Hazard
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . · FDA Class II
Units
3,672 unitsin total
Sold at
US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
Description
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Product
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →