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

Date

May 24, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Completed

Filed by

IMMUNDIAGNOSTIK, Inc

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

Marketed without a 510k

Distribution pattern

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

Quantity

88 units

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

Recall started

March 27, 2023

Device type

Lactoferrin, Antigen, Antiserum, Control

Root cause (FDA)

No Marketing Application

What the company told customers

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

Recall number

Z-1603-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1603-2023. The agency record governs; check it and the company before acting.