Z-0673-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- November 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 US; 167 OUS
Product Description
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
Reason for Recall
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
Distribution Pattern
Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, Egypt, France, Germany, Ghana, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, S. Korea, Spain, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.
Code Information
UDI-DI 15099590201937 Lots 338921 339071 372223 439138 439205 439206 439207 439650 439801 439889 440026 440090 472012 472092 472136 472154