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Beckman Coulter Inc. recalls ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI:
Recalled August 18, 2021 · FDA recall Z-2257-2021 · Beckman Coulter
Hazard
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . · FDA Class II
Units
544 units
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 QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →