Beckman Coulter IgA Test Kits: Lipemic Interference Issue

Take action

Contact the company & request your remedy

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd, N/A · Brea, CA 92821-6232

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Beckman Coulter is recalling IgA test kits that may have lipemic interference issues. This could affect test accuracy if used properly. The recall does not include a specific fix or return process.

Why it’s dangerous

The test kits may not work correctly when blood samples have high fat content (lipemic samples). This could lead to inaccurate IgA test results if the interference fails to meet performance specifications.

Who’s affected

Lab users who purchased the IgA test kits with UDI code (01)15099590011574 are affected. Those using these kits for medical testing may be at risk of inaccurate results.

How to tell if you have this one

Check the UDI code on the kit packaging for (01)15099590011574. The kits are labeled as IgA, 4 x 14 mL R1 and 4 x 11 mL R2.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit UDI Code
Look for the UDI code (01)15099590011574 on the product packaging.

✎ GovInfoNow

Questions people ask

Is there a fix for these test kits?

The recall notice does not specify any remedy or fix for the test kits.

How can I tell if I have the recalled test kits?

Check the UDI code on the packaging for (01)15099590011574. The kits are labeled as IgA, 4 x 14 mL R1 and 4 x 11 mL R2.

Do I need to stop using these test kits?

The recall does not require stopping use; however, the kits may not work correctly if lipemic interference occurs.

Take action

Contact Beckman Coulter

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

✉️ Open in email

Subject: Recall Z-2488-2023 — Beckman Coulter Beckman Coulter

Hello,

I own a Beckman Coulter that is covered by recall Z-2488-2023 from Beckman Coulter.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2488-2023 (July 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2488-2023 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.

Beckman Coulter Inc. recalls Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Recall notice