VEO Diagnostics Recalls ACCEL ELISA COVID-19 Antibody Test Kits
VEO Diagnostics is recalling 15 ACCEL ELISA COVID-19 antibody test kits because the FDA removed their Emergency Use Authorization. Users should stop using the kits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
VEO Diagnostics, LLC is recalling 15 kits of the ACCEL ELISA COVID-19 test, used for the detection of total antibodies to SARS-CoV-2. The affected products are identified by catalog number AE301U and specific kit lots PXCOV073020 and PXCOV081220, with expiration dates of January 18, 2021, and January 26, 2021.
The recall was initiated because the U.S. Food and Drug Administration removed the Emergency Use Authorization (EUA) for these specific COVID-19 antibody tests. The agency classified this action as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The affected kits were distributed nationwide in the United States, including in the states of Iowa, Pennsylvania, and Washington. Users of these specific test kits should stop using them immediately and contact VEO Diagnostics for further instructions.
The recalled product
- 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
- Manufacturer
- VEO DIAGNOSTICS, LLC
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Kit lots: PXCOV073020
- PXCOV081220 Expiration dates: January 18
- 2021 and January 26
- 2021
Distribution
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