🔍 RecallPedia

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

Class I - Dangerous
🏥 Medical Devices Recalled: November 2, 2017 Epigenomics Ag Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Number: 16903908; Expiration Date: 28 Feb 2018
  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:
Epigenomics Ag
Reason for Recall:
The diagnostic test kit may produce invalid test runs which may delay test results.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

Product Codes/Lot Numbers:

Lot Number: 16903908; Expiration Date: 28 Feb 2018

Distribution:

Distributed in: NY, CA, MI, NC, NE, NJ, PA, TN, TX, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1077-2018