Kamiya Biomedical Company, LLC: Medical Device Recall in 2022 - (Recall #: Z-0271-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 28, 2022

Date Posted: November 30, 2022

Recall Number: Z-0271-2023

Event ID: 91030

Reason for Recall:

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

Status: Ongoing

Product Quantity: 165

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.

Voluntary or Mandated:

Voluntary: Firm initiated