Manchester, NH, United States
IMMUNDIAGNOSTIK, Inc recalls
1 recall recorded since 2018, most recently on 27 March 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 27 March 2023
- Reason
- Marketed without a 510k
- Distribution
- US Nationwide Distribution: CA, IL, NC, NH, OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1603-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.