K-ASSAY IgA Immunoturbidimetric Assay — Class II medical device recall Z-0271-2023
Ongoing recall by Kamiya Biomedical Company, LLC, reported 2022-11-30, distributed nationwide. IgA Reagent may start showing cloudiness over time, which can affect assay performance.
| Recall number | Z-0271-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kamiya Biomedical Company, LLC, Tukwila, WA, United States |
| Recall initiated | 2022-09-28 |
| Classified | 2022-11-21 |
| Reported by FDA | 2022-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ |
| Quantity | 165 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00816426020092 |
| Lot numbers | D283, H180, K181, N182 |
| Model numbers | KAI-013 |
Product
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Reason for recall
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0271-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.