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U.S. Department of Health and Human Services

Class 2 Device Recall Immundiagnostik AG

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 Class 2 Device Recall Immundiagnostik AGsee related information
Date Initiated by FirmMarch 27, 2023
Date PostedMay 18, 2023
Recall Status1 Completed
Recall NumberZ-1603-2023
Recall Event ID 92131
Product Classification Lactoferrin, antigen, antiserum, control - Product Code DEG
ProductImmundiagnostik 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
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
Recalling Firm/
Manufacturer		 IMMUNDIAGNOSTIK, Inc
400 Bedford St Ste 104
Manchester NH 03101-1195
For Additional Information Contactsame
888-433-9020
Manufacturer Reason
for Recall		Marketed without a 510k
FDA Determined
Cause 2		No Marketing Application
ActionImmundiagnostik 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 Commerce88 units
DistributionUS Nationwide Distribution: CA, IL, NC, NH, OR
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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