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Lower risk Medical device recall · FDA · Published August 14, 2023

Microbiologics KWIK-STIK QC Set Recall: Missing Strain Risk

Microbiologics recalls KWIK-STIK ANA QC Set (Lot 5065-26) due to missing strain 6018P Parabacteroides distasonis in microbiological testing.

🇺🇸 FDA recall #Z-2576-2023Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling a specific QC set for microbiological testing because one lot is missing a critical strain. This could affect test accuracy if used without the full set. Read more at govinfonow.com/recall/57489-microbiologics-kwik-stik-qc-set-recall-missing-strain-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57489-microbiologics-kwik-stik-qc-set-recall-missing-strain-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2576-2023

Cite this page

“Microbiologics KWIK-STIK QC Set Recall: Missing Strain Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57489-microbiologics-kwik-stik-qc-set-recall-missing-strain-risk. Based on FDA recall #Z-2576-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2023%22&limit=1).

The FDA announced on Aug. 14, 2023, that Microbiologics Inc voluntarily recalled one lot of KWIK-STIK, ANA (3 Strains) QC Set due to microbiological testing issues. The hazard involves a missing strain in the quality control set.

How to tell if you have it

  • Brand: Microbiologics
  • Product: KWIK-STIK, ANA (3 Strains) QC Set
  • REF: 5065P
  • UDI/DI: 70845357025622
  • Lot Number: 5065-26
  • Expiration Date: 07/31/2024

The hazard

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, specifically Parabacteroides distasonis. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Microbiologics Inc has issued 35 other recalls since June 6, 2017. Recent brand recalls include a Dec. 2, 2025, KWIK-STIK 2-Pack recall for microorganism recovery risk and a Nov. 13, 2025, quality control kit recall involving lot labeling mix-ups. Other recent recalls of similar products include the July 29, 2026, Diagnostica Stago STA Staclot Protein S Recall and the Dec. 5, 2025, Meridian Bioscience Revogene C. difficile Test Recall.

How to tell if you have this one

Check for the lot number 5065-26 on the packaging. The product was sold with expiration date 07/31/2024. This specific QC set is used for microbiological testing.

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

What to do — step by step

  1. Check Product Lot Number

    Look for lot number 5065-26 on the packaging to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of MN, PA, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Minnesota, Pennsylvania, Tennessee, Texas.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Aug 14, 202312. FDA classified it Class III: Sep 11, 202323. Published in FDA’s Enforcement Report: Sep 20, 202332023
  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-2576-2023 (August 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2576-2023 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