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Lower risk Medical device recall · FDA · Published May 16, 2019

Microbiologics Cepheid Xpert C. difficile/Epi Control Panel Recall: Incorrect Expiration

Microbiolog: Cepheid Xpert C. difficile/Epi Control Panel has incorrect expiration date (2021-10-31 vs 2021-03-31). Affected units may expire before intended use.

🇺🇸 FDA recall #Z-1838-2019Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics recalls a specific batch of Cepheid Xpert C. difficile/Epi Control Panels due to an incorrect expiration date. Using these panels after the intended expiration date could lead to expired products that may not function properly. Read more at govinfonow.com/recall/67919-microbiologics-cepheid-xpert-c-difficile-epi-control-panel-recall-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/67919-microbiologics-cepheid-xpert-c-difficile-epi-control-panel-recall-incorrect · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1838-2019

Cite this page

“Microbiologics Cepheid Xpert C. difficile/Epi Control Panel Recall: Incorrect Expiration.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67919-microbiologics-cepheid-xpert-c-difficile-epi-control-panel-recall-incorrect. Based on FDA recall #Z-1838-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1838-2019%22&limit=1).

The FDA announced on May 16, 2019, that Microbiologics Inc is recalling Cepheid Xpert C. difficile/Epi Control Panels because the expiration date was incorrectly labeled as Oct. 31, 2021, instead of March 31, 2021.

How to tell if you have it

  • Brand: Microbiologics
  • Product: Cepheid Xpert C. difficile/Epi Control Panel
  • UDI: 70845357041370
  • Lot Number: 8200-26
  • Quantity: 22 units

The hazard

The product is labeled with an expiration date of Oct. 31, 2021, when it should be March 31, 2021.

Context

GovInfoNow's records show Microbiologics Inc has issued 35 other recalls since June 6, 2017. Recent Microbiologics recalls include a Dec. 2, 2025 LYFO DISK recall for risk of failed microorganism recovery and a Nov. 13, 2025 KWIK-STIK Quality Control Kit recall for lot labeling mix-ups. Other recent recalls of similar products include the LimFlow Vector Product Recall (Dec. 5, 2025), Cook Medical Spectrum Central Venous Tray Recall (March 5, 2026), and HiResolution Bionic Ear System Recall (April 30, 2026).

How to tell if you have this one

Check for the unique device identifier (UDI) 70845357041370 and lot number 8200-26 on the panel. The product was sold with an incorrect expiration date of 2021-10-31 instead of 2021-03-31.

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

What to do — step by step

  1. Check Expiration Date

    Verify the expiration date on the panel matches the correct date of 2021-03-31. If it shows 2021-10-31, it is affected.

Where it went and when

Where it was distributed

Distributed in 11 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Georgia, Minnesota, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: May 16, 201912. FDA classified it Class III: Jun 18, 201923. Published in FDA’s Enforcement Report: Jun 26, 201932019
  1. Firm started the recall
  2. FDA classified it Class III
  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-1838-2019 (May 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1838-2019 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