Z-1342-2021Class II

LIAISON 1-84 PTH Assay -

Name: Z-1342-2021 LIAISON 1-84 PTH Assay -
Creator: Diasorin Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2020-11-23 / Terminated

FDA source

Diasorin Inc. began a recall of LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone... on 2020-11-23. FDA classified it as Class II and gives the reason as "Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1342-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Posted: 2021-04-01
Terminated: 2023-07-06
Recalling firm: Diasorin Inc.
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.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 5,895 devices
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.
Product codes and lots: REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1342-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1342-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-04-01

Product code CEW

K150879Class IILIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc. / cleared 2015-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)