Device product
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.
Z-1342-2021
Product summary
- Firm
- Diasorin Inc.
- Event
- Event 87501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,895 devices
- Official record key
device-enforcement:Z-1342-2021
Official wording
Reason: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Code information: REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.