🔍 RecallPedia

Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Class I - Dangerous
🏥 Medical Devices Recalled: December 16, 2019 Microbiologics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
  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:
Microbiologics Inc
Reason for Recall:
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Product Codes/Lot Numbers:

Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0812-2020

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