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;
Reported: August 18, 2021 Initiated: July 1, 2021 #Z-2257-2021
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 .
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 544 units
- Distribution
- 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
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Beckman Coulter Inc.. Units affected: 544 units.
Why was this product recalled? ▼
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2257-2021.
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