Recall Z-1342-2021— Diasorin Inc.
Class II · Terminated
Class II FDA medical device recall by Diasorin Inc., initiated 2020-11-23, terminated 2023-07-06. It names one FDA 510(k) clearance: K150879. 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.. Reason: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples..
- Recalling firm
- Diasorin Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-23
- Terminated
- 2023-07-06
- Firm location
- Stillwater, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Data sourced from openFDA. This site is unofficial and independent of the FDA.