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K-ASSAY® Complement C4 Reagent
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-010 · UDI-DI 00816426020085
DBI
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
32
Facilities
Description
For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the re |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
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