COVID-19 Antibody Test Kit Recalled for Failing Validation Requirements
Thera Test Laboratories is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits distributed across six states because they failed to meet FDA's updated validation requirements for accurately detecting COVID-19 antibodies.
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: This is a risk-of-harm product where no injuries have been reported. The device's failure to meet FDA's positive percent agreement requirement means it may not adequately detect COVID-19 antibodies, creating a theoretical risk of false-negative results. No illnesses or injuries are reported in the source text.
Plain-English summary
Thera Test Laboratories, Inc. is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits (Catalog #104-129) distributed nationwide in California, Florida, Illinois, Indiana, North Carolina, and Texas.
The kits are being recalled because they did not meet updated FDA EUA (Emergency Use Authorization) requirements for positive percent agreement, meaning the tests were not adequately validated. This failure could result in the test not accurately detecting COVID-19 antibodies.
The affected lot numbers are 05204350 (expiring 05/01/2021), 05204367 (expiring 05/19/2021), and 06204432 (expiring 05/19/2021).
Consumers and healthcare providers who have these kits should discontinue use and contact Thera Test Laboratories, Inc. with questions.
The recalled product
- Product
- EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
- Manufacturer
- Thera Test Laboratories, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 11
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 (6)
- Kit lot numbers 05204350
- exp. 05/01/2021
- 05204367
- exp. 05/19/2021
- and 06204432
- exp. 05/19/2021.
Distribution
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