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K-ASSAY® IgM Reagent
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-015 · UDI-DI 00816426020115
CFF
Prescription
1
510(k) clearances
2
Adverse events
4
Recalls
7
Facilities
Description
For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-28 | Kamiya Biomedical Company, LLC | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| 2022-04-06 | Helena Laboratories, Corp. | Due to microbial growth causing interference with interpretation. |
| 2017-07-21 | Helena Laboratories, Corp. | The plates do not have wells punched for the controls in the patient 1 area. |
| 2004-01-28 | Beckman Coulter Inc | Inconsistent and incomplete results for IgG. |
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