LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON¿ Analyzer family.
Enforcement
- Recall Number
- Z-1342-2021
- Event ID
- 87501
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Diasorin Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 7, 2021
- Initiation Date
- November 23, 2020
- Classification Date
- April 1, 2021
- Termination Date
- July 6, 2023
- Address
- 1951 Northwestern Ave S, Stillwater, MN, 55082-7536, United States
Description
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON¿ Analyzer family.
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Worldwide distribution - US Nationwide in the states of KY, OH, GA, PA, FL and the countries of Canada, Argentina, Bahrain, Bosnia & Herzegovnia, Iraq, Jordan, Morocco, Nepal, Russia, Serbia, Singapore, Taiwan, Thailand, Tunisia, Dubai, Italy, Israel, Brazil, Mexico, Australia, and Bulgaria.
5,895 devices