Lower riskMedical device recall · FDA · Published March 17, 2021
Clark Laboratories recalls measles IgM test kit due to potential invalid results
Clark Laboratories recalls Trinity Biotech Captia Measles IgM Kit (Catalog No. 2326060) that may produce invalid test results due to control issues. Affected kits expire June 2021.
“Clark Laboratories recalls measles IgM test kit due to potential invalid results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63049-clark-laboratories-recalls-measles-igm-test-kit-due-to-potential. Based on FDA recall #Z-1503-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1503-2021%22&limit=1).
Clark Laboratories, Inc. recalled the Trinity Biotech Captia Measles IgM Kit (Catalog No. 2326060) on March 17, 2021, according to the FDA. The Positive Control may run high out of its assigned ISR range, resulting in an invalid run and necessitating retesting.
How to tell if you have it
Brand: Clark Laboratories
Product: Trinity Biotech Captia Measles IgM Kit
Catalog No.: 2326060
Kit Lot: 2326060-060
Expiration Date: 2021-06-28
UDI: 05391516743655
Quantity: 80 kits
Distribution: US Nationwide and Ireland
The hazard
The Positive Control may run high out of its assigned ISR range. This condition results in an invalid run that necessitates retesting.
Context
GovInfoNow's records show Clark Laboratories, Inc. has one other recall on record since October 11, 2021. On October 11, 2021, the company issued a recall for the Bartels Legionella Urinary Antigen Kit due to invalid assay risks. Other recent recalls of similar products include the Sperm Ab ELISA Test Kit Recall (July 2, 2026), the Abbott ID NOW Influenza A & B 2 Kit (February 9, 2026), and the GET TESTED Mycoplasma Test Recall (November 3, 2025).
How to tell if you have this one
Check for the catalog number 2326060 on the kit. The expiration date is June 28, 2021, and the kit is for detecting measles antibodies in blood samples.
Brand
Clark Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration
Look for the expiration date of June 28, 2021, on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Ireland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1503-2021 (March 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1503-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.