Z-2258-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 1, 2021
- Termination Date
- June 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,672 unitsin total
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 .
Distribution Pattern
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
Code Information
All Lots