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Beckman Coulter Inc. Recall 88261

Description: 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;

Beckman Coulter Inc. Recall 88261 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2257-2021
Event ID88261
Event DescriptionACCESS 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;
Product TypeDevices
DistributionUS 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
Quantity544 units
Recall ReasonSARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Device Classification20210818
Device Code InfoAll Lots
Center Classification Date20210812
Recall Initiation Date20210701
Recalling FirmBeckman Coulter Inc.
Initial Notification Letter
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