Z-1603-2023Class II

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of...

Name: Z-1603-2023 Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of...
Creator: IMMUNDIAGNOSTIK, Inc
Published: 2023-03-27
License: https://open.fda.gov/license/

Immundiagnostik AG / initiated 2023-03-27 / Completed

FDA source

IMMUNDIAGNOSTIK, Inc began a recall of Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N... on 2023-03-27. FDA classified it as Class II and gives the reason as "Marketed without a 510k". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1603-2023
Classification: Class II
Status: Completed
Initiated: 2023-03-27
Posted: 2023-05-18
Recalling firm: Immundiagnostik AG
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
Product code: DEG Lactoferrin, Antigen, Antiserum, Control
Reason for recall: Marketed without a 510k
FDA root cause: No Marketing Application
Action: Immundiagnostik initiated the recall on Monday March 27, 2023 via email/telephone. Letter Urgent: Field Corrective Action Product Recall, states reason for recall, health risk and action to take: Effective immediately, we ask that you discard all unused kits of the IDK Lactoferrin ELISA and discontinue use of the product pending clarification by the FDA. If you have any questions related to this letter or the response, please contact IDK customer support at (888) 433-9020 x1006
Quantity in commerce: 88 units
Distribution: US Nationwide Distribution: CA, IL, NC, NH, OR
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2023	Class II	Completed	Voluntary: Firm initiated	2023-05-24	2023-05-17

Product code DEG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)