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Recall Observatory FDA recall evidence

Device 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.

Z-1342-2021

November 23, 2020

Class II

Product summary

Firm
Diasorin Inc.
Event
Event 87501
Status
Terminated
Classification
Class II
Quantity
5,895 devices
Official record key
device-enforcement:Z-1342-2021

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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