CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
Accel Elisa Covid-19 for the detection of total antibodies recalled
Veo Diagnostics is recalling Accel Elisa Covid-19 for the detection of total antibodies to Sars-CoV-2, distributed nationwide in the US. The recall was initiated on 5 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0510-2021
- FDA event ID
- 86798
- Recalling firm
- Veo Diagnostics, Loveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2020
- FDA classified
- 1 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Nov 2020 | Recall initiated by company | |
| 1 Dec 2020 | Classified by FDA | +26 days |
| 9 Dec 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution including in the states of IA, PA, WA.
Questions about this recall
Is Accel Elisa Covid-19 for the detection of total antibodies to Sars-CoV-2 recalled?
Yes. Veo Diagnostics recalled Accel Elisa Covid-19 for the detection of total antibodies to Sars-CoV-2 on 5 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0510-2021.
Why was it recalled?
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Which lots are affected?
Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Where was it sold?
US Nationwide distribution including in the states of IA, PA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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