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.
- Company
- Diasorin Inc.
- Recall Initiated
- November 23, 2020
- Terminated
- July 6, 2023
- Recall Number
- Z-1342-2021
- Quantity
- 5,895 devices
- Firm Location
- Stillwater, MN
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.
Lot / Code Info
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Root Cause
Under Investigation by firm
Action Taken
A Recall notification letter titled, "Urgent DIASORIN CUSTOMER NOTIFICATION LETTER" was sent to consignees on 11/23/2020 via email. The letter instructs the consignee to stop using the LIAISON 1-84 PTH Assay (REF 310630) lot numbers 134909, 134909A, 134909B, and destroy any remaining inventory. They are asked to please complete the bottom portion of the letter and return to DiaSorin to obtain replacement product. The consignee is also instructed to forward the letter to anyone who may be impacted at their facility or anyone these kits have been distributed to outside of the consignee's organization.