IMMUNDIAGNOSTIK, Inc: Medical Device Recall in 2023 - (Recall #: Z-1603-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 27, 2023

Date Posted: May 24, 2023

Recall Number: Z-1603-2023

Event ID: 92131

Reason for Recall:

Marketed without a 510k

Status: Completed

Product Quantity: 88 units

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated