Clark Laboratories, Inc. Recall 87637
Description: Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Clark Laboratories, Inc. Recall 87637 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1503-2021 |
| Event ID | 87637 |
| Event Description | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Ireland. |
| Quantity | 80 kits |
| Recall Reason | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting |
| Device Classification | 20210505 |
| Device Code Info | Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655 |
| Center Classification Date | 20210427 |
| Recall Initiation Date | 20210317 |
| Recalling Firm | Clark Laboratories, Inc. |
| Initial Notification | Letter |
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