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Recall Observatory FDA recall evidence

Device product

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.

Z-1503-2021

March 17, 2021

Class II

Product summary

Firm
Clark Laboratories, Inc.
Event
Event 87637
Status
Terminated
Classification
Class II
Quantity
80 kits
Official record key
device-enforcement:Z-1503-2021

Official wording

Reason: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

Code information: Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655

Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Ireland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting