Reported May 5, 2021 · Terminated

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

Clark Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Clark Laboratories, Inc. · 2823 Girts Rd · Jamestown, NY · 14701-9666

Is this the product you have?

  • Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 -
  • Product Usageintended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection
Lot codes and dates
  • Kit Lot2326060-060
  • Expiration Date2021-06-28 (UDI): 05391516743655
Amount recalled
80 kits

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Clark Laboratories, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 29, 2022 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.