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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Remel BactiDrop Acridine Orange Recalled for Incorrect Test Results

Agency Publication Date: October 30, 2024
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Summary

Remel, Inc. has recalled 29 kits of BactiDrop Acridine Orange (REF 21502) because the solution inside the droppers can change color from orange-yellow to light yellow. This chemical change leads to test results that do not meet specifications and could result in inaccurate laboratory findings. No injuries or incidents have been reported in connection with this issue.

Risk

The solution color change results in out-of-specification fluorescent stains, which could lead to incorrect diagnostic results in a laboratory setting.

What You Should Do

  1. This recall involves Remel BactiDrop Acridine Orange kits (REF 21502), packaged with 50 droppers per kit, specifically from Lot 733100 with an expiration date of 2025-04-04 (UDI-DI 848838000447).
  2. Stop using the recalled product immediately.
  3. Contact Remel, Inc. or your distributor to arrange for a return, replacement, or correction of the affected kits.
  4. If you have additional questions, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: remel BactiDrop Acridine Orange (50 per package)
Model / REF:
21502
Lot Numbers:
733100 (Exp. 2025-04-04)
UDI:
848838000447

Recall number Z-0266-2025; total quantity affected is 29 kits.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95458
Status: Active
Manufacturer: Remel, Inc
Sold By: Government distribution; Laboratory distributors
Manufactured In: United States
Units Affected: 29 kits
Distributed To: Illinois, Indiana, Minnesota, Nebraska, South Dakota, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.