Z-0510-2021Class II

ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots...

Name: Z-0510-2021 ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots...
Creator: Veo Diagnostics, Llc
Published: 2020-11-05
License: https://open.fda.gov/license/

Veo Diagnostics, LLC / initiated 2020-11-05 / Terminated / root cause: design

FDA source

VEO DIAGNOSTICS, LLC began a recall of 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... on 2020-11-05. FDA classified it as Class II and gives the reason as "Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0510-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-05
Posted: 2020-12-01
Terminated: 2021-04-16
Recalling firm: Veo Diagnostics, LLC
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
Product code: QMN Covid-19 Multi-Analyte Antigen Device
Reason for recall: Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Root cause tag: design
FDA root cause: Device Design
Action: Plexense issued NOTICE IMPORTANT PRODUCT WITHDRAWAL dated 11/5/20, stating reason for withdrawal, health risk and action take: clinical decisions. " If this test has been used to make clinical decisions, evaluate each patients clinical presentation and medical history, whether prior test results generated using this test may have been incorrect, and whether the patient should be retested using an FDA-authorized test. " Complete the Customer Response Form that accompanies this letter and return it to VEO Diagnostics, Plexenses US distributor, to confirm that you have received and understand this Notification. VEOs return address is listed on the Customer Response Form. " Remove from your stock any remaining ACCEL ELISA COVID-19 tests that you have in your possession and discard those kits. Indicate their destruction or disposal on the Customer Notification Form. You DO NOT need to return the kits to VEO Diagnostics or Plexense, Inc. " If you were using ACCEL ELISA COVID-19 for research purposes, and you wish to continue with your research, please contact VEO Diagnostics at 513-965-3140 for assistance with obtaining replacement materials to continue your research. Should you have additional questions regarding this Notification, or if you need assistance, please contact VEO Diagnostics Product Support team at: Telephone : 513-965-3140 Fax : 513-961-2858
Quantity in commerce: 15 kits
Distribution: US Nationwide distribution including in the states of IA, PA, WA.
Product codes and lots: Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-01

Product code QMN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)