🔍 RecallPedia

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

Class I - Dangerous
🏥 Medical Devices Recalled: July 4, 2014 Advandx Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot Number: 04914 Exp. Date: 2015-06
  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:
Advandx Inc
Reason for Recall:
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

Product Codes/Lot Numbers:

Lot Number: 04914 Exp. Date: 2015-06

Distribution:

Distributed in: AZ, ID, FL, MO, OH, MI, NJ, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2138-2014

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