Tukwila, WA, United States
Kamiya Biomedical Company, LLC recalls
1 recall recorded since 2018, most recently on 28 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 September 2022
- Reason
- IgA Reagent may start showing cloudiness over time, which can affect assay performance.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0271-2023
- K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.