🔍 RecallPedia

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Class I - Dangerous
🏥 Medical Devices Recalled: November 5, 2012 Beckman Coulter Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872
  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:
Beckman Coulter Inc.
Reason for Recall:
Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Product Codes/Lot Numbers:

Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0572-2013

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Beckman Coulter

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