FDA Enforcement
Class II
Terminated
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Recall: Z-2258-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2258-2021
- Event ID
- 88261
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 18, 2021
- Initiation Date
- July 1, 2021
- Classification Date
- August 12, 2021
- Termination Date
- June 14, 2023
- Address
- 250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States
Description
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Reason
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Code Info
All Lots
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
Quantity
3,672 unitsin total