Z-1603-2023 Class II
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
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 for Recall
Marketed without a 510k
Distribution Pattern
US Nationwide Distribution: CA, IL, NC, NH, OR
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