Thera Test Laboratories, Inc. Recall 88477
Description: EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories, Inc. Recall 88477 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2381-2021 |
| Event ID | 88477 |
| Event Description | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX. |
| Quantity | 11 kits |
| Recall Reason | Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129 |
| Device Classification | 20210908 |
| Device Code Info | Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021. |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20200730 |
| Recalling Firm | Thera Test Laboratories, Inc. |
| Initial Notification | Letter |
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