Recall Z-1342-2021 ยท CEW Radioimmunoassay, Parathyroid Hormone
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 LIA
| Date | Nov 23, 2020 |
| Status | Terminated |
| Reason | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. |
| 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 organiz |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers DiaSorin, Inc., Jun 22, 2015 |