Reported Nov 30, 2022 · Ongoing

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

Kamiya Biomedical Company, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Kamiya Biomedical Company, LLC · 12779 Gateway Dr S · Tukwila, WA · 98168-3308

Is this the product you have?

  • K-ASSAY IgA Immunoturbidimetric Assay
  • REFKAI-013
Lot codes and dates
  • UDI-DI00816426020092
  • Lot/ Expiration Date
    • H180/ 2023-01-31
    • K181/ 2023-03-31
    • N182/ 2023-06-30
    • D283/ 2023-09-30
Amount recalled
165

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

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