Recall Z-1503-2021— Clark Laboratories, Inc.

Name: FDA recall Z-1503-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-17

Class II · Terminated

Class II FDA medical device recall by Clark Laboratories, Inc., initiated 2021-03-17, terminated 2022-06-29. It names one FDA 510(k) clearance: K140455. 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.. Reason: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting.

Recalling firm: Clark Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-17
Terminated: 2022-06-29
Firm location: Jamestown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K140455 — CAPTIA MEASLES IGMTrinity Biotech USA·cleared 2014-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.