bioMerieux NUCLISENS easyMAG Magnetic Silica Kit: Potential Contamination Risk

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Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

bioMerieux is recalling a specific lab kit for DNA testing due to a risk of false test results from contamination. This could lead to incorrect health conclusions if used without proper handling.

Why it’s dangerous

The extraction reagents in the kit may become contaminated, causing test results to be delayed or inaccurate. This could lead to incorrect health conclusions if the kit is used without proper handling.

Who’s affected

Lab users and healthcare professionals who purchased the NUCLISENS easyMAG Magnetic Silica kit (REF 280133) with lot numbers Z012MK1MS through Z013AL1MS. Those using the kit for diagnostic testing are most at risk.

How to tell if you have this one

Check the lot number on the kit's packaging. Affected lots include Z012MK1MS, Z012ML1MS, Z012NB1MS, and Z013AL1MS, which expire by November 2022 through January 2023.

Brand
bioMerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the kit's packaging to determine if it's affected.

✎ GovInfoNow

Questions people ask

What is the specific risk with this kit?

The extraction reagents may become contaminated, causing delayed or inaccurate test results.

Which lot numbers are affected?

Affected lots are Z012MK1MS, Z012ML1MS, Z012NB1MS, and Z013AL1MS, expiring by November 2022 through January 2023.

Do I need to stop using this kit?

No specific stop-use instruction is given; check the lot number to see if it's affected.

Take action

Contact bioMerieux

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

✉️ Open in email

Subject: Recall Z-1564-2022 — bioMerieux bioMerieux

Hello,

I own a bioMerieux that is covered by recall Z-1564-2022 from bioMerieux.

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-1564-2022 (July 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1564-2022 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.

bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

Lower-risk recall