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Lower risk Medical device recall · FDA · Published July 20, 2022

bioMerieux NUCLISENS easyMAG Magnetic Silica Kit: Potential Contamination Risk

bioMerieux recalls NUCLISENS easyMAG Magnetic Silica kits (REF 280133) with possible contamination leading to delayed test results. Affected lots expire by December 2022 to January 2023.

🇺🇸 FDA recall #Z-1564-2022Medical devicebioMerieux ›
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Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/60336-biomerieux-nuclisens-easymag-magnetic-silica-kit-potential-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60336-biomerieux-nuclisens-easymag-magnetic-silica-kit-potential-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1564-2022

Cite this page

“bioMerieux NUCLISENS easyMAG Magnetic Silica Kit: Potential Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60336-biomerieux-nuclisens-easymag-magnetic-silica-kit-potential-contamination-risk. Based on FDA recall #Z-1564-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2022%22&limit=1).

The FDA announced on July 20, 2022, that bioMerieux, Inc. is recalling NUCLISENS easyMAG Magnetic Silica kits due to a potential for no or delayed results from contaminated extraction reagents. The agency issued recall number Z-1564-2022 for the Class II voluntary recall.

How to tell if you have it

  • Brand: bioMerieux
  • Product: NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit
  • Lot numbers: Z012MK1MS (exp. 28-NOV-2022), Z012ML1MS (exp. 28-NOV-2022), Z012NB1MS (exp. 28-DEC-2022), Z013AL1MS (exp. 28-JAN-2023)
  • UDI: 03573026139339
  • Units affected: 1,301 kits
  • Distribution states: AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, VA

The hazard

According to the FDA, there is a potential for no result leading to possible delayed result due to contamination of extraction reagents.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include Medline Convenience Kits Recall: Contaminated Components Risk (July 10, 2026), Medline Convenience Kits Recall: Fungal Contamination Risk (Aug. 11, 2026), and Medline Neuro Pack Kits Contaminated with Bacillus Species - Recall (June 11, 2026).

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

  1. Check Lot Number

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

Where it went and when

Where it was distributed

Distributed in 24 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: yesMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Jul 20, 202212. FDA classified it Class II: Aug 23, 202223. Published in FDA’s Enforcement Report: Aug 31, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

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.

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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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA