Thera Test Laboratories, Inc. Recall 88478
Description: EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test Laboratories, Inc. Recall 88478 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2382-2021 |
| Event ID | 88478 |
| Event Description | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas. |
| Quantity | 19 kits |
| Recall Reason | The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128 |
| Device Classification | 20210908 |
| Device Code Info | Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021. |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20201005 |
| Recalling Firm | Thera Test Laboratories, Inc. |
| Initial Notification | Letter |
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