---
title: "Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay... — FDA record Z-1016-2023 | Is It on Recall"
description: "Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits."
url: https://isitonrecall.com/recall/fda-device-z-1016-2023-future-diagnostics-stat-intraoperative-intact-pth-stat-io-i-pth-immunoassay-kit-ref-4k-ipt-00-in-vit/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic. — FDA record Z-1016-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 6, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- **Reason**: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
- **Classification**: Class II
- **Recalling firm**: Future Diagnostics Solutions B.V.
- **Quantity**: 342 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1016-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Feb 1, 2023
- **Recall initiation date**: Dec 6, 2022
- **Center classification date**: Jan 25, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Future Diagnostics Solutions B.V. records](https://isitonrecall.com/brand/future-diagnostics-solutions-b-v/)