EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Reported: September 8, 2021 Initiated: October 5, 2020 #Z-2382-2021
Product Description
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Reason for Recall
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Details
- Recalling Firm
- Thera Test Laboratories, Inc.
- Units Affected
- 19 kits
- Distribution
- US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
- Location
- Lombard, IL
Frequently Asked Questions
What product was recalled? ▼
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128. Recalled by Thera Test Laboratories, Inc.. Units affected: 19 kits.
Why was this product recalled? ▼
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2382-2021.
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