Z-1503-2021 Class II Terminated
FDA device recall Z-1503-2021 was initiated by Clark Laboratories, Inc. on March 17, 2021 and is designated Class II. Reason for recall: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting The recall status is terminated (terminated June 29, 2022). Affected quantity: 80 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- June 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 kits
Product 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.
Reason for Recall
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Ireland.
Code Information
Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655