FDA Medical Device Recalls (openFDA)
VEO DIAGNOSTICS, LLC: 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 number
- Z-0510-2021
- 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
- Status
- Terminated
- Initiated
- 2020-11-05
- Posted
- not on file
- Terminated
- 2021-04-16
- Reason
- Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
- 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
- 15 kits
- Distribution
- US Nationwide distribution including in the states of IA, PA, WA.
- Lot, serial or model codes
- Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QMN
- Firm FEI
- 3017223053
- Firm city
- Loveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28