IMMUNDIAGNOSTIK, Inc recalls Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in sto…

Recall date

March 27, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1603-2023

FDA classification

Class II

Brand / firm

IMMUNDIAGNOSTIK, Inc

Sold / distributed

US Nationwide Distribution: CA, IL, NC, NH, OR

Why it was recalled

Marketed without a 510k

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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