medical Class II Updated 2021-04-07

Diasorin Inc. recalls LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemi

Recalled 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.


Hazard / Issue

Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
View official government recall

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