Z-0510-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- November 5, 2020
- Termination Date
- April 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Product Description
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Reason for Recall
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Distribution Pattern
US Nationwide distribution including in the states of IA, PA, WA.
Code Information
Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021