Recall Z-1603-2023— IMMUNDIAGNOSTIK, Inc

Name: FDA recall Z-1603-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-27

Class II · Completed

Class II FDA medical device recall by IMMUNDIAGNOSTIK, Inc, initiated 2023-03-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Marketed without a 510k.

Recalling firm: IMMUNDIAGNOSTIK, Inc
Classification: Class II
Status: Completed
Initiated: 2023-03-27
Firm location: Manchester, NH, United States

Product description

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

Reason for recall

Marketed without a 510k

Data sourced from openFDA. This site is unofficial and independent of the FDA.