🔍 RecallPedia

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Class I - Dangerous
🏥 Medical Devices Recalled: August 8, 2018 Helena Laboratories Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Kit lots 2-17-5651, exp. 8/31/2018, and 3-17-5651, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.
  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:
Helena Laboratories, Corp.
Reason for Recall:
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Product Codes/Lot Numbers:

Kit lots 2-17-5651, exp. 8/31/2018, and 3-17-5651, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1950-2019

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