FDA recall Z-0271-2023

Kamiya Biomedical Company, LLC · Class II · device

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.

Distribution

Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.

Key facts

Status
Ongoing
Initiation date
2022-09-28
Report date
2022-11-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tukwila, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2023