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Lower risk Medical device recall · FDA · Published July 23, 2018

Qiagen EZ1 Advanced XL Recall: Power PCB Issue May Compromise Nucleic Acid Extractions

Qiagen recalls EZ1 Advanced XL model 9001492 due to potential heater malfunction from a power PCB issue, which may require repeating nucleic acid extractions and delaying results.

🇺🇸 FDA recall #Z-0383-2019Medical deviceQiagen ›
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Recalling firmQiagen Sciences LLC19300 Germantown Rd · Germantown, MD 20874-1415
✎ GovInfoNow plain-language explainer

Qiagen is recalling its EZ1 Advanced XL instrument model 9001492 because a power branching printed circuit board issue could cause heater malfunctions. This might lead to failed nucleic acid extractions, requiring users to repeat tests and delaying results from downstream applications. Read more at govinfonow.com/recall/70309-qiagen-ez1-advanced-xl-recall-power-pcb-issue-may-compromise.

Source Summary by GovInfoNow · govinfonow.com/recall/70309-qiagen-ez1-advanced-xl-recall-power-pcb-issue-may-compromise · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0383-2019

Cite this page

“Qiagen EZ1 Advanced XL Recall: Power PCB Issue May Compromise Nucleic Acid Extractions.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70309-qiagen-ez1-advanced-xl-recall-power-pcb-issue-may-compromise. Based on FDA recall #Z-0383-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0383-2019%22&limit=1).

Qiagen Sciences LLC recalled EZ1 Advanced XL instruments on July 23, 2018, according to the Food and Drug Administration. The agency announced the voluntary Class II recall due to a potential heater malfunction that could compromise nucleic acid extractions.

How to tell if you have it

  • Brand: Qiagen
  • Product: EZ1 Advanced XL
  • Model Number: 9001492
  • GTIN/UPC: 04053228010760

The hazard

A defect in the power branching printed circuit board may trigger a heater malfunction. If this occurs, nucleic acid extractions could be compromised and require repetition, causing delays in obtaining results from downstream applications.

Context

Qiagen Sciences LLC has 16 other recalls on record since June 5, 2019. Recent Qiagen recalls include the March 12, 2025 QIAstat-Dx Respiratory Panel Plus recall for faulty cartridges and the June 3, 2024 QIAcube Connect MDx Recall for a heater shaker module issue. Other recent recalls of similar products include the Dec. 15, 2025 Philips Allura Xper FD10C Medical System Recall for electrical short-circuit risks and the July 8, 2026 Tobii Dynavox TD Navio Maxi Speech Device Recall for battery short circuit risk.

How to tell if you have this one

Check for the model number 9001492 on the EZ1 Advanced XL instrument. The product was sold with GTIN 04053228010760 and is designed for use with QIAGEN kits for nucleic acid purification.

  • Brand
    Qiagen
  • Product
    EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Instrument Model

    Verify the model number on your EZ1 Advanced XL instrument to confirm if it is 9001492.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Florida, Georgia, Idaho, Illinois, Iowa, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Virginia, Washington.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Jul 23, 201812. FDA classified it Class II: Nov 3, 201823. Published in FDA’s Enforcement Report: Nov 14, 201834. FDA terminated the recall: Jun 5, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0383-2019 (July 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0383-2019 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.
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