🔍 RecallPedia

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

Class I - Dangerous
🏥 Medical Devices Recalled: May 24, 2016 Hardy Diagnostics Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All units manufactured between October 2014 and May 2016.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Hardy Diagnostics
Reason for Recall:
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

Product Codes/Lot Numbers:

All units manufactured between October 2014 and May 2016.

Distribution:

Distributed in: CA, TX, NE, OK, LA, NC, PA, AZ, NY, VA, NM, MI, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2146-2016

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