FDAClass IIMay 5, 2021

Trinity Biotech Captia Measles IgM Kit recall

Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human…

Why was Trinity Biotech Captia Measles IgM Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human…
Recalling firm
Clark Laboratories, Inc.
Quantity
80 kits
Distribution
Worldwide distribution - US Nationwide distribution and the country of Ireland.
Recall date
May 5, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls