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Lower risk Medical device recall · FDA · Published January 8, 2024

Microbiologics Enteric Pathogens Control Panel Recall: Contaminated Negative Control

Microbiologics recalls Enteric Pathogens Control Panel (REF 8184) due to contaminated negative control causing false Norovirus positives. Affected lots include 8184-65 to 8184-71. No remedy specified.

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

🇺🇸 FDA recall #Z-1075-2024Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling its Enteric Pathogens Control Panel (REF 8184) because the negative control was contaminated with Norovirus. This means users might get false positive results for Norovirus when running the negative control test. The recall affects specific lot numbers with expiration dates through May 2025. Read more at govinfonow.com/recall/56395-microbiologics-enteric-pathogens-control-panel-recall-contaminated-negative-control.

Source Summary by GovInfoNow · govinfonow.com/recall/56395-microbiologics-enteric-pathogens-control-panel-recall-contaminated-negative-control · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1075-2024

Cite this page

“Microbiologics Enteric Pathogens Control Panel Recall: Contaminated Negative Control.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56395-microbiologics-enteric-pathogens-control-panel-recall-contaminated-negative-control. Based on FDA recall #Z-1075-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2024%22&limit=1).

The FDA announced on Jan. 8, 2024, that Microbiologics Inc is recalling its Enteric Pathogens Control Panel (Inactivated Pellet) due to Norovirus contamination in the negative control. The agency issued recall number Z-1075-2024 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Microbiologics
  • Product: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184
  • Lot codes: 8184-65, 8184-66, 8184-67, 8184-68, 8184-69, 8184-70, 8184-71
  • Expiry dates: 3/31/2025, 4/30/2025, 5/31/2025, 6/30/2025, 8/31/2025
  • UDI-DI: 70845357041448
  • Quantity: 580 packages

The hazard

According to the FDA, the negative control was contaminated with Norovirus, one of the positive control pathogens. This contamination would result in users getting a positive call for Norovirus when running the negative control.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since 2017-06-06. Recent brand recalls include a Dec. 2, 2025, recall of KWIK-STIK 6-Pack units for microorganism recovery failure and a Nov. 13, 2025, recall of Quality Control Kits due to lot labeling mix-ups. Other recent recalls of similar products include the Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), the BioFire Spotfire Respiratory Panel Recall (April 1, 2026), and the GET TESTED Mycotoxin Panel Test Recall (Nov. 3, 2025).

How to tell if you have this one

Check the product label for lot numbers 8184-65 through 8184-71. The expiration date for these lots ranges from March 31, 2025, to August 31, 2025. The product is labeled as Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet).

  • Brand
    Microbiologics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for lot numbers 8184-65 to 8184-71 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 8, 202412. FDA classified it Class II: Feb 12, 202423. Published in FDA’s Enforcement Report: Feb 21, 202432024
  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.

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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-1075-2024 (January 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1075-2024 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