FDA recall Z-1342-2021

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.

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.

Key facts

Status

Terminated

Initiation date

2020-11-23

Report date

2021-04-07

Termination date

2023-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stillwater, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2021