# FDA recall Z-1016-2023

> **Future Diagnostics Solutions B.V.** · Class II · device recall initiated 2022-12-06.

## Product

Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

## Reason for recall

Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

## Distribution

Worldwide distribution.  US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom

## Key facts

- **Recall number:** Z-1016-2023
- **Recalling firm:** Future Diagnostics Solutions B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-06
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wijchen, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2023

## Citation

> AI Analytics. FDA recall Z-1016-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1016-2023. Source: US FDA. Licensed CC0.

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