EL-Anti-SARS-CoV-2 IgG Kit recall
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Why was EL-Anti-SARS-CoV-2 IgG Kit recalled?
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
- Product
- EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Recalling firm
- Thera Test Laboratories, Inc.
- Quantity
- 19 kits
- Distribution
- US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)