🔍 RecallPedia

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Class I - Dangerous
🏥 Medical Devices Recalled: March 21, 2016 Hardy Diagnostics Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot H16054 and H15056.
  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:
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Product Codes/Lot Numbers:

Lot H16054 and H15056.

Distribution:

Distributed in: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1571-2016

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