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Lower risk Medical device recall · FDA · Published September 20, 2024

Remel BactiDrop Acridine Orange Recall: Color Change Causes Inaccurate Test Results

Remel recalls BactiDrop Acridine Orange (REF 21502) due to color change from orange-yellow to light yellow causing inaccurate fluorescent stain results. Affected lots expire April 2025.

🇺🇸 FDA recall #Z-0266-2025Medical deviceRemel ›
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Recalling firmRemel, Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519
✎ GovInfoNow plain-language explainer

Remel is recalling Bacti:Drop Acridine Orange test kits because a color change in the solution can lead to inaccurate test results. This affects kits with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/53940-remel-bactidrop-acridine-orange-recall-color-change-causes-inaccurate-test.

Source Summary by GovInfoNow · govinfonow.com/recall/53940-remel-bactidrop-acridine-orange-recall-color-change-causes-inaccurate-test · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0266-2025

Cite this page

“Remel BactiDrop Acridine Orange Recall: Color Change Causes Inaccurate Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53940-remel-bactidrop-acridine-orange-recall-color-change-causes-inaccurate-test. Based on FDA recall #Z-0266-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2025%22&limit=1).

The FDA announced on September 20, 2024, that Remel, Inc. is recalling remel BactiDrop Acridine Orange kits due to a potential color change in the solution. This defect can result in out-of-specification fluorescent stain results for laboratory testing.

How to tell if you have it

  • Brand: Remel
  • Product: remel BactiDrop Acridine Orange, REF 21502, 50 per package
  • Lot code: 733100
  • Expiration date: 2025-04-04
  • UDI-DI: 848838000447

The hazard

A color change of the solution within the dropper can occur from orange-yellow to light yellow. This results in out-of-specification fluorescent stain results.

Context

GovInfoNow's records show Remel, Inc. has had 22 other recalls since November 2, 2017. Other recent recalls of similar products include Remel GC Agar Base Recall (June 3, 2026), Remel Yeastone Broth Recall (March 24, 2026), and Remel Campy CVA Medium 100/PK recall (February 5, 2026). Other recent recalls of similar products include Oxoid Listeria Kits May Give Incorrect Results (March 3, 2026) and Remel Oxoid Agglutinating Sera Recall (March 25, 2026).

How to tell if you have this one

Check the lot number on the packaging, which should be 733100 for this recall. The product expires on April 4, 2025. The product code is REF 21502 with 50 kits per package.

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

What to do — step by step

  1. Check Product Details

    Verify the lot number (733100) and expiration date (April 4, 2025) on the packaging.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: yesSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Indiana, Minnesota, Nebraska, South Dakota, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Sep 20, 202412. FDA classified it Class II: Oct 30, 202423. Published in FDA’s Enforcement Report: Nov 6, 202432024
  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-0266-2025 (September 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0266-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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