Diasorin Inc. recalls LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative

Recalled April 7, 2021 · FDA recall Z-1342-2021 · Diasorin

Hazard

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

Units

5,895 devices

Sold at

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.

Description

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

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.

Manufacturer(s)

Diasorin Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →