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Lower risk Medical device recall · FDA · Published February 12, 2020

Microbiologics QC Sets Contain Wrong Fungus - Recall for Safety

Microbiologics recalls QC sets and panels that may contain Candida instead of Trichosporon dermatis, a potential safety risk for lab users.

🇺🇸 FDA recall #Z-1691-2020Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling QC sets and panels that may contain Candida instead of the intended Trichosporon dermatis fungus. This could cause inaccurate lab results or contamination risks for users. Read more at govinfonow.com/recall/65854-microbiologics-qc-sets-contain-wrong-fungus-recall-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/65854-microbiologics-qc-sets-contain-wrong-fungus-recall-for-safety · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1691-2020

Cite this page

“Microbiologics QC Sets Contain Wrong Fungus - Recall for Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65854-microbiologics-qc-sets-contain-wrong-fungus-recall-for-safety. Based on FDA recall #Z-1691-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2020%22&limit=1).

The FDA announced on Feb. 12, 2020, that Microbiologics Inc is recalling Microbiologics QC SETS AND PANELS and KWIKSTIK kits because they may contain Candida Utilis instead of the labeled Trichosporon dermatis. The recall affects 49 units distributed nationwide and internationally.

How to tell if you have it

  • Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P
  • KWIKSTIK 2 Pack (REF 0778P)
  • Lot Numbers: 5195-04, 5195-05
  • UPC: 70845357030770

The hazard

The recalled KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels (REF 5195P) contain product labeled as Trichosporon dermatis which may contain Candida Utilis instead of T. dermatis, according to the FDA.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls include a Dec. 2, 2025 KWIK-STIK 2-Pack recall for microorganism recovery risk and a Nov. 13, 2025 KWIK-STIK Quality Control Kit recall for lot labeling mix-ups. Similar recent recalls of similar products include a March 24, 2026 Remel Yeastone Broth Recall for incorrect lab results risk and an Aug. 11, 2026 Medline Convenience Kits Recall for fungal contamination risk.

How to tell if you have this one

Check for the product name 'KWIKSTIK YST Comprehensive QC Set' with reference number 5195P. Lot numbers 5195-04 or 5195-05 are affected.

  • Brand
    Microbiologics
  • Product
    Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
Recall numberProduct, codes & lots
Z-1690-2020KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3); Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.
Z-1691-2020Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.; Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name and reference number to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Feb 12, 202012. FDA classified it Class II: Apr 9, 202023. Published in FDA’s Enforcement Report: Apr 15, 202034. FDA terminated the recall: Mar 26, 2021420202021
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury?

The recall indicates a potential for inaccurate lab results, but no serious injury risk is mentioned.

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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-1691-2020 (February 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1691-2020 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