Recall Z-1603-2023 ยท DEG Lactoferrin, Antigen, Antiserum, Control
IMMUNDIAGNOSTIK, Inc
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
| Date | May 18, 2023 (initiated Mar 27, 2023) |
| Status | Completed |
| Reason | Marketed without a 510k |
| 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 | 88 units |
| Distribution | US Nationwide Distribution: CA, IL, NC, NH, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.