# FDA recall Z-1342-2021

> **Diasorin Inc.** · Class II · device recall initiated 2020-11-23.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1342-2021
- **Recalling firm:** Diasorin Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-23
- **Report date:** 2021-04-07
- **Termination date:** 2023-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stillwater, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2021

## Citation

> AI Analytics. FDA recall Z-1342-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1342-2021. Source: US FDA. Licensed CC0.

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