Z-0094-2025 Class II Ongoing
FDA device recall Z-0094-2025 was initiated by Beckman Coulter, Inc. on Aug 28, 2024 and is designated Class II. Reason for recall: Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. The recall status is ongoing. Affected quantity: 2805 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Aug 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2805 units
Product 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.
Reason for Recall
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Code Information
UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0094-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026