Diasorin Inc. Recall 87501
Description: 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.
Diasorin Inc. Recall 87501 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1342-2021 |
| Event ID | 87501 |
| Event Description | 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 Type | 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. |
| Quantity | 5,895 devices |
| Recall Reason | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. |
| Device Classification | 20210407 |
| Device Code Info | REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125 |
| Center Classification Date | 20210401 |
| Recall Initiation Date | 20201123 |
| Recalling Firm | Diasorin Inc. |
| Initial Notification | |
| Similar To |