FDA Enforcement
Class II
Terminated
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
Recall: Z-0510-2021
·
Reported December 9, 2020
Enforcement
- Recall Number
- Z-0510-2021
- Event ID
- 86798
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- VEO DIAGNOSTICS, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 9, 2020
- Initiation Date
- November 5, 2020
- Classification Date
- December 1, 2020
- Termination Date
- April 16, 2021
- Address
- 422 Wards Corner Rd, N/A, Loveland, OH, 45140-6964, United States
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
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Code Info
Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Distribution
US Nationwide distribution including in the states of IA, PA, WA.
Quantity
15 kits