Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk
Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical diagnostic) where the defect necessitates retesting, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Clark Laboratories, Inc. is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060. The product is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected of measles (rubeola) infection. The affected lot number is 2326060-060 with an expiration date of June 28, 2021, and UDI 05391516743655.
The recall was initiated because the Positive Control may run high out of its assigned ISR range. This defect can result in an invalid run and necessitate retesting. The agency has classified this recall as Class II.
The product was distributed worldwide, including US Nationwide distribution and the country of Ireland. Users of the affected kits should stop using them and contact the recalling firm for instructions on retesting or replacement.
The recalled product
- 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.
- Manufacturer
- Clark Laboratories, Inc.
- Hazard
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
Distribution
Distributed nationwide across the United States.
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