ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013
  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:
Instrumentation Laboratory Co.
Reason for Recall:
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Product Codes/Lot Numbers:

Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2247-2013

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