🔍 RecallPedia

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

Class I - Dangerous
🏥 Medical Devices Recalled: January 15, 2016 OraSure Technologies Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item Number 1001-0343, Lot # 6648737
  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:
OraSure Technologies, Inc.
Reason for Recall:
OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

Product Codes/Lot Numbers:

Item Number 1001-0343, Lot # 6648737

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1509-2016

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