Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.
What this means for you
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: This is an FDA Class II recall for a medical device marketed without required 510(k) premarket notification. The device represents a risk-of-harm product because it was distributed without FDA validation of safety and effectiveness. No clinical injuries or illnesses have been reported.
Plain-English summary
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit, an in vitro enzyme immunoassay test used to measure lactoferrin levels in stool samples. The recalled product includes 88 units distributed nationwide across California, Illinois, North Carolina, New Hampshire, and Oregon.
The product was marketed without the required FDA 510(k) premarket notification. The 510(k) process is FDA's pathway for manufacturers to demonstrate that a device is substantially equivalent to a legally marketed device, ensuring adequate safety and effectiveness before distribution.
Affected lot numbers include 220706 (expiration 05/04/2024), 221122 (expiration 06/07/2024), 221124 (expiration 07/29/2025), and 230102 (expiration 10/24/2025).
Healthcare providers, laboratories, and others who have received this product should discontinue use immediately. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
- Manufacturer
- IMMUNDIAGNOSTIK, Inc
- Hazard
- uncleared-device
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 (3)
- UDI: (01) 04050598000582 PN K6870/Lot Numbers: 220706 Exp. 05/04/2024
- 221122 Exp. 06/07/2024. P/N:K6870.20.US.L Lot Numbers: 221124 Exp:07/29/2025
- 230102 Exp: 10/24/2025
Distribution
Distributed nationwide across the United States.
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