🔍 RecallPedia

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Class I - Dangerous
🏥 Medical Devices Recalled: August 28, 2024 Beckman Coulter Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251
  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:
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Product Codes/Lot Numbers:

UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0094-2025

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Beckman Coulter

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DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Beckman Coulter

Class I - Dangerous

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

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