FDA Device recall Z-0271-2023
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- FDA Device
- Class II
- ongoing
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 by Kamiya Biomedical, citing igA Reagent may start showing cloudiness over time, which can affect assay performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0271-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-28 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Kamiya Biomedical |
| Distribution | US |
Product
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Reason
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Identifiers
| code_info | UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2023%22
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