Lower risk Medical device recall · FDA · Published October 8, 2018

Biomerieux NucliSENS easyMAG Lysis Buffer Recall: Colored Eluates Due to Hemoglobin

Biomerieux recalls NucliSENS easyMAG Lysis Buffer (ref. 280134) due to potential colored eluates from residual hemoglobin. Affected units were sold with specific lot number and expiration date.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0443-2019Medical device Biomerieux ›

Lower-risk recall

Some eluates become colored because of remaining hemoglobin in the eluate.

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Contact the company

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

✎ GovInfoNow plain-language explainer

Biomerieux is recalling its NucliSENS easyMAG Lysis Buffer product because some samples may turn colored due to leftover hemoglobin. This could affect lab results and requires checking the lot number and expiration date. Read more at govinfonow.com/recall/69659-biomerieux-nuclisens-easymag-lysis-buffer-recall-colored-eluates-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/69659-biomerieux-nuclisens-easymag-lysis-buffer-recall-colored-eluates-due-to · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0443-2019

Cite this page

“Biomerieux NucliSENS easyMAG Lysis Buffer Recall: Colored Eluates Due to Hemoglobin.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69659-biomerieux-nuclisens-easymag-lysis-buffer-recall-colored-eluates-due-to. Based on FDA recall #Z-0443-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2019%22&limit=1).

The FDA announced on Oct. 8, 2018, that bioMerieux, Inc. is recalling the bioMérieux NucliSENS easyMAG Lysis Buffer due to potential discoloration from remaining hemoglobin. The agency issued recall number Z-0443-2019 for the Class II device.

How to tell if you have it

Brand: Biomerieux
Product: bioMérieux NucliSENS easyMAG Lysis Buffer
Reference: ref. 280134
Lot code: Z019EA1LB
Expiration date: 28-MAY-2019
Quantity: 268 units

The hazard

Some eluates become colored because of remaining hemoglobin in the eluate, according to the FDA.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (Jan. 5, 2026). Other recent recalls of similar products include GEM Premier 7000 with iQM3 (May 21, 2026), Instrumentation Laboratory GEM Premier 5000 PAK (May 21, 2026), and Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026).

How to tell if you have this one

Check for the lot number Z019EA1LB and expiration date of May 28, 2019 on the product label. The product is identified as NucliSENS easyMAG Lysis Buffer with reference number 280134.

Brand
Biomerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number Z019EA1LB and expiration date of May 28, 2019 on the product label.

Where it went and when

Where it was distributed

Distributed in 19 states, and outside the U.S.

FDA distribution: “CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Georgia, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Oct 8, 2018Firm started the recall
Nov 9, 2018FDA classified it Class II
Nov 21, 2018Published in FDA’s Enforcement Report
May 21, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall is for potential inaccurate lab results, not a risk of serious injury. This is a low-risk issue.

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Link to this recall

<a href="https://govinfonow.com/recall/69659-biomerieux-nuclisens-easymag-lysis-buffer-recall-colored-eluates-due-to">Biomerieux NucliSENS easyMAG Lysis Buffer Recall: Colored Eluates Due to Hemoglobin (GovInfoNow)</a>

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-0443-2019 (October 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0443-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.