Recall Z-2257-2021— Beckman Coulter Inc.
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 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;. 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 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;
Reason for recall
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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