FDA recall Z-1603-2023

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 for recall

Marketed without a 510k

Distribution

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

Key facts

Status

Completed

Initiation date

2023-03-27

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Manchester, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2023