LIAISON 1-84 PTH Assay — Class II medical device recall Z-1342-2021
Terminated recall by Diasorin Inc., reported 2021-04-07, distributed nationwide. Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
| Recall number | Z-1342-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasorin Inc., Stillwater, MN, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2023-07-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BG, BH, BR, CA, IL, IQ, IT, JO, MA, MX, NP, RS, RU, SG, TH, TN, TW |
| Quantity | 5,895 devices |
| UPC / GTIN / UDI-DI | 08056771600125 |
| Lot numbers | 134909, 134909A, 134909B |
| Model numbers | 310630 |
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 for recall
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1342-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.