Device product

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

Z-0271-2023

September 28, 2022

Class II

Product summary

Firm: Kamiya Biomedical Company, LLC
Event: Event 91030
Status: Ongoing
Classification: Class II
Quantity: 165
Official record key: device-enforcement:Z-0271-2023

Official wording

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

Code information: UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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