Z-1342-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- November 23, 2020
- Termination Date
- July 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,895 devices
Product 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.
Reason for Recall
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
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.
Code Information
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125