Recall Z-0271-2023— Kamiya Biomedical Company, LLC

Name: FDA recall Z-0271-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by Kamiya Biomedical Company, LLC, initiated 2022-09-28. It names one FDA 510(k) clearance: K993213. Product: K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013. Reason: IgA Reagent may start showing cloudiness over time, which can affect assay performance..

Recalling firm: Kamiya Biomedical Company, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: Tukwila, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K993213 — K-ASSAY IGAKamiya Biomedical Co.·cleared 1999-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

Reason for recall

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.