FDA recall Z-0510-2021

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 for recall

Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

Distribution

US Nationwide distribution including in the states of IA, PA, WA.

Key facts

Status

Terminated

Initiation date

2020-11-05

Report date

2020-12-09

Termination date

2021-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Loveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2021