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Lower risk Medical device recall · FDA · Published May 1, 2025

Remel Thermo Scientific Sensititre Cation Adjusted AutoRead Broth Recall: Off Color Risk

Remel recalls Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth with potential off color affecting performance. Learn if you have the product and what to do.

🇺🇸 FDA recall #Z-1947-2025Medical deviceRemel ›
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Contact the company

Recalling firmRemel, Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519
✎ GovInfoNow plain-language explainer

What happened, in plain English

Remel is recalling a specific lab culture product due to a possible off color that could affect its performance. This issue might lead to inaccurate test results in laboratory settings. Read more at govinfonow.com/recall/52358-remel-thermo-scientific-sensititre-cation-adjusted-autoread-broth-recall-off.

Source Summary by GovInfoNow · govinfonow.com/recall/52358-remel-thermo-scientific-sensititre-cation-adjusted-autoread-broth-recall-off · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1947-2025

Cite this page

“Remel Thermo Scientific Sensititre Cation Adjusted AutoRead Broth Recall: Off Color Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52358-remel-thermo-scientific-sensititre-cation-adjusted-autoread-broth-recall-off. Based on FDA recall #Z-1947-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2025%22&limit=1).

Why it’s dangerous

The product may have an off color that affects its performance. This could lead to inaccurate test results in laboratory settings. The hazard is related to the product's appearance rather than physical harm.

Who’s affected

Laboratory users who have the specific Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth with REF CP11410. Those using this product for diagnostic tests are most at risk of inaccurate results.

How to tell if you have this one

Check for the product name 'Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth' with REF CP11410. The product was sold as an in vitro diagnostic device with UDI/DI 848838018855 and lot 226414.

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

What to do — step by step

  1. Check Product Details

    Identify if you have the Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth with REF CP11410.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Georgia, Kentucky, Virginia.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: May 1, 202512. FDA classified it Class II: Jun 11, 202523. Published in FDA’s Enforcement Report: Jun 18, 202532025
  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-1947-2025 (May 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1947-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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