Diasorin Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
REF 310630, lot numbers: 134909, 134909A and 134909B, UDI: 08056771600125
Products Sold
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
Diasorin Inc. is recalling LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended due to Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026