ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Reported: August 18, 2021 Initiated: July 1, 2021 #Z-2258-2021
Product Description
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
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
- 3,672 unitsin total
- 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 EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017. Recalled by Beckman Coulter Inc.. Units affected: 3,672 unitsin total.
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-2258-2021.
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