FDAClass IIMay 24, 2023

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme recall

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N…

Why was Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme recalled?

Marketed without a 510k

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N…
Recalling firm
IMMUNDIAGNOSTIK, Inc
Quantity
88 units
Distribution
US Nationwide Distribution: CA, IL, NC, NH, OR
Recall date
May 24, 2023
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls