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
Reported: May 24, 2023 Initiated: March 27, 2023 #Z-1603-2023
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
Details
- Recalling Firm
- IMMUNDIAGNOSTIK, Inc
- Units Affected
- 88 units
- Distribution
- US Nationwide Distribution: CA, IL, NC, NH, OR
- Location
- Manchester, NH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by IMMUNDIAGNOSTIK, Inc. Units affected: 88 units.
Why was this product recalled? ▼
Marketed without a 510k
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1603-2023.
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