EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Reported: September 8, 2021 Initiated: July 30, 2020 #Z-2381-2021
Product Description
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Reason for Recall
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Details
- Recalling Firm
- Thera Test Laboratories, Inc.
- Units Affected
- 11 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
- Location
- Lombard, IL
Frequently Asked Questions
What product was recalled? ▼
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129. Recalled by Thera Test Laboratories, Inc.. Units affected: 11 kits.
Why was this product recalled? ▼
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2381-2021.
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