FDA Medical Device Recalls (openFDA)
Future Diagnostics Solutions B.V.: Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- Recall number
- Z-1016-2023
- Recalling firm
- Future Diagnostics Solutions B.V.
- Product
- Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- Status
- Open, Classified
- Initiated
- 2022-12-06
- Posted
- 2023-01-25
- Terminated
- not on file
- Reason
- Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
- Root cause
- Under Investigation by firm
- Action
- 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 fieldsafety@future-diagnostics.nl.
- Quantity
- 342 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
- Lot, serial or model codes
- Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
- 510(k) numbers
- ["K000471"]
- PMA numbers
- not on file
- Product code
- CEW
- Firm FEI
- 3001857593
- Firm city
- Wijchen
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28