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
Check against the official notice below — it lists the full affected range.
DiaSorin Inc. is recalling the LIAISON 1-84 PTH Assay, an in vitro diagnostic system used to measure parathyroid hormone levels in blood samples. The system has the potential to produce falsely elevated parathyroid hormone results from patient samples. The recall affects 5,895 devices with reference number 310630 and lot numbers 134909, 134909A, and 134909B that were distributed worldwide, including in Kentucky, Ohio, Georgia, Pennsylvania, and Florida in the United States, as well as numerous countries including Canada, Australia, Brazil, Mexico, and others.
The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Reason for recall: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. Distribution: 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. Quantity: 5,895 devices Lot/code info: REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.