medical Class II Updated 2021-08-18

Beckman Coulter Inc. recalls ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0

Recalled 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;


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots
View official government recall

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