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Lower risk Medical device recall · FDA · Published July 1, 2021

Gibson Bioscience KOH 10% Solution Recall: Hydrogen Peroxide Contamination Hazard

Gibson Bioscience recalls KOH 10% solution (Cat. No. 300145) due to hydrogen peroxide contamination. This may cause unintended reactions during lab use. Affected lots include 21137116 with UDI 10634853000633.

🇺🇸 FDA recall #Z-2450-2021Medical deviceGibson Bioscience ›
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Recalling firmGibson Bioscience1040 Manchester St · Lexington, KY 40508-2422
✎ GovInfoNow plain-language explainer

Gibson Bioscience is recalling Potassium Hydroxide 10% solution (Cat. No. 300145) because some batches were contaminated with hydrogen peroxide instead of pure KOH. This could lead to unexpected chemical reactions during lab work, especially when handling biological samples. Read more at govinfonow.com/recall/62252-gibson-bioscience-koh-10-solution-recall-hydrogen-peroxide-contamination-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/62252-gibson-bioscience-koh-10-solution-recall-hydrogen-peroxide-contamination-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2450-2021

Cite this page

“Gibson Bioscience KOH 10% Solution Recall: Hydrogen Peroxide Contamination Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62252-gibson-bioscience-koh-10-solution-recall-hydrogen-peroxide-contamination-hazard. Based on FDA recall #Z-2450-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2450-2021%22&limit=1).

The FDA announced on July 1, 2021, that Gibson Bioscience is recalling Potassium Hydroxide 10% (KOH 10%) because a lot was manufactured with Hydrogen Peroxide 3% instead of the correct chemical. The agency issued recall number Z-2450-2021 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Gibson Bioscience
  • Product: Potassium Hydroxide 10% (KOH 10%)
  • Catalog No.: 300145
  • Lot Code: 21137116
  • UDI: 10634853000633

The hazard

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. The product is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations.

Context

GovInfoNow's records show Gibson Bioscience has a history of recalls, including this Class II voluntary action from July 1, 2021. Other recent recalls of similar products include Medline Blood Culture Kit Recall: Open Seal Risk in BD ChloraPrep Swabsticks (2025-12-24), Hologic ThinPrep CytoLyt Solution Recall: Fungal Contamination Risk (2025-12-12), and Instrumentation Laboratory Coagulation Test Kits Risk Microbial Contamination (2025-12-11).

How to tell if you have this one

Check the lot number on the container, which should be 21137116 for this recall. The unique device identifier (UDI) is 10634853000633. This product is used for fungal identification in clinical labs.

  • Brand
    Gibson Bioscience
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the lot number (21137116) and unique device identifier (UDI) 10634853000633 on the container.

Where it went and when

Where it was distributed

Distributed in 7 states.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: 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: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Kentucky, Maine, New York, North Carolina, South Carolina.

Recall timeline

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

1. Firm started the recall: Jul 1, 202112. FDA classified it Class II: Sep 10, 202123. Published in FDA’s Enforcement Report: Sep 22, 202134. FDA terminated the recall: May 2, 2023420212023
  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-2450-2021 (July 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2450-2021 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