Recall Z-0510-2021— VEO DIAGNOSTICS, LLC

Name: FDA recall Z-0510-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-05

Class II · Terminated

Class II FDA medical device recall by VEO DIAGNOSTICS, LLC, initiated 2020-11-05, terminated 2021-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.

Recalling firm: VEO DIAGNOSTICS, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-11-05
Terminated: 2021-04-16
Firm location: Loveland, OH, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.