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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