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Completed

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

FDA Recall Z-1603-2023 · Posted 2023-05-18

Recalling FirmIMMUNDIAGNOSTIK, Inc
Recall StatusCompleted
Product CodeDEG
Date Initiated2023-03-27
Product Quantity88 units

Reason for Recall

Marketed without a 510k

Firm 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

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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