Kamiya Biomedical Company, LLC Recall 91030
Description: K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Kamiya Biomedical Company, LLC Recall 91030 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0271-2023 |
| Event ID | 91030 |
| Event Description | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic. |
| Quantity | 165 |
| Recall Reason | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| Device Classification | 20221130 |
| Device Code Info | UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30 |
| Center Classification Date | 20221121 |
| Recall Initiation Date | 20220928 |
| Recalling Firm | Kamiya Biomedical Company, LLC |
| Initial Notification | Letter |
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