Kamiya K-ASSAY IgA Assay Recall: Cloudiness Affects Test Results

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Recalling firmKamiya Biomedical Company, LLC12779 Gateway Dr S, N/A · Tukwila, WA 98168-3308

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Kamiya is recalling its K-ASSAY IgA Immunoturbidimetric Assay (REF: KAI-013) because the reagent may develop cloudiness over time, which can lead to inaccurate test results. This issue affects specific batches with known expiration dates and lot numbers.

Why it’s dangerous

The IgA reagent may become cloudy over time, which can cause the test results to be inaccurate. This cloudiness is a gradual change that occurs in the reagent solution.

Who’s affected

Lab users who purchased the K-ASSAY IgA Immunoturbidimetric Assay (REF: KAI-013) with lot numbers H180, K181, N182, or D283 are most at risk. These units have expiration dates through January 2023 to September 2023.

How to tell if you have this one

Check the product label for the lot number (H180, K181, N182, or D283) and expiration date (through January 2023 to September 2023). The product is sold under the reference number KAI-013.

Brand
Kamiya
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot number (H180, K181, N182, or D283) and expiration date on the product label.

✎ GovInfoNow

Questions people ask

What is the product being recalled?

Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay (REF: KAI-013).

Why is this product being recalled?

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

What lot numbers are affected?

Lot numbers H180 (expires Jan 2023), K181 (Mar 2023), N182 (Jun 2023), and D283 (Sep 2023).

Take action

Contact Kamiya

We’ve drafted a message you can send Kamiya to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0271-2023 — Kamiya Kamiya

Hello,

I own a Kamiya that is covered by recall Z-0271-2023 from Kamiya.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0271-2023 (September 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0271-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

Lower-risk recall