🔍 RecallPedia

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

Class I - Dangerous
🏥 Medical Devices Recalled: November 9, 2020 Helena Laboratories Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT
  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:
Due to complaints received associated with cracked/split test tube caps.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

Product Codes/Lot Numbers:

Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0635-2021

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