Future Diagnostics STAT-IntraOperative-Intact-PTH… recallZ-1016-2023 · Future Diagnostics Solutions B.V. · initiated Dec 6, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Future Diagnostics Solutions B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
FDA root cause category: Under Investigation by firm
What the company is doing
On 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV. As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result. Actions to be taken by customers: -Immediately identify and quarantine the affected lot numbers. -Further instructions will be provided by the Future Diagnostics. For questions, send an email to [email protected].
Recall details
- Recall number
- Z-1016-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 6, 2022
- Posted by the FDA
- Jan 25, 2023
- Recalling firm
- Future Diagnostics Solutions B.V.
- Quantity
- 342 kits
- Product code
- CEW
- FDA submissions
- K000471
- 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
Product description
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Code information (models, lots, serial numbers)
Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Future Diagnostics 4K-IPT-00Future Diagnostics Solutions B.V. · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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