Diasorin Inc.: Medical Device Recall in 2021 - (Recall #: Z-1342-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: April 7, 2021

Recall Number: Z-1342-2021

Event ID: 87501

Reason for Recall:

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

Status: Terminated

Product Quantity: 5,895 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated