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U.S. Department of Health and Human Services

Class 2 Device Recall ACCEL ELISA COVID19 Test

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  Class 2 Device Recall ACCEL ELISA COVID19 Test see related information
Date Initiated by Firm November 05, 2020
Create Date December 01, 2020
Recall Status1 Terminated 3 on April 16, 2021
Recall Number Z-0510-2021
Recall Event ID 86798
Product Classification COVID-19 Multi-Analyte Antigen Device - Product Code QMN
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
Code Information Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Recalling Firm/
Manufacturer		 VEO DIAGNOSTICS, LLC
422 Wards Corner Rd
Loveland OH 45140-6964
Manufacturer Reason
for Recall		 Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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