Immundiagnostik recalls IDK Lactoferrin ELISA kits for stool lactoferrin testing due to being marketed without FDA 510(k) clearance. This in vitro diagnostic kit may not be safe for use without proper regulatory approval.
Marketed without a 510k
Immundiagnostik is recalling its IDK Lactoferrin ELISA kits for stool lactoferrin testing because they were marketed without FDA 510(k) clearance. This means the product may not be safe for use without proper regulatory approval.
The kits were marketed without FDA 510(k) clearance, which is required for in vitro diagnostic devices in the U.S. This means the product may not have been tested for safety and effectiveness before being sold.
People who purchased the Immundiagnostik IDK Lactoferrin ELISA kits for stool testing are affected. Those using the kits for medical purposes without FDA approval may be at risk.
Check for product codes: K6870 or K6870.20.US.L. The kits were sold with specific lot numbers and expiration dates listed in the recall notice.
Look for product codes K6870 or K6870.20.US.L on the kit packaging.
The product was recalled because it was marketed without FDA 510(k) clearance, which is required for in vitro diagnostic devices in the U.S.
This kit is intended for determining lactoferrin levels in stool samples.
Check for product codes K6870 or K6870.20.US.L on the kit packaging.
We’ve drafted a message you can send Immundiagnostik to request your refund or repair — edit it as you like.
Subject: Recall Z-1603-2023 — Immundiagnostik Immundiagnostik Hello, I own a Immundiagnostik that is covered by recall Z-1603-2023 from Immundiagnostik. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
