Z-2256-2021 Class II Terminated
FDA device recall Z-2256-2021 was initiated by Beckman Coulter Inc. on July 1, 2021 and is designated Class II. Reason for recall: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . The recall status is terminated (terminated June 14, 2023). Affected quantity: 451 units.
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
- 451 units
Product Description
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
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