Reported May 24, 2023 · Completed

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in…

IMMUNDIAGNOSTIK, 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: IMMUNDIAGNOSTIK, Inc · 400 Bedford St Ste 104 · Manchester, NH · 03101-1195

Is this the product you have?

  • Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool
  • P/NK6870
  • Single Kit P/NK6870.20.US.L 20 Plates
Lot codes and dates
  • UDI(01) 04050598000582
  • PN K6870/Lot Numbers
    • 220706 Exp. 05/04/2024
    • 221122 Exp. 06/07/2024
  • P/NK6870.20.US
  • L Lot Numbers221124
  • Exp
    • 07/29/2025
    • 230102
  • Exp10/24/2025
Amount recalled
88 units

Where it was sold

Why it was recalled

Marketed without a 510k

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 IMMUNDIAGNOSTIK, 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

Data as of Sep 19, 5:38 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.