Z-1016-2023Class II

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

Name: Z-1016-2023 Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro...
Creator: Future Diagnostics Solutions B.V.
Published: 2022-12-06
License: https://open.fda.gov/license/

Future Diagnostics Solutions B.V. / initiated 2022-12-06 / Open, Classified

FDA source

Future Diagnostics Solutions B.V. began a recall of Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic on 2022-12-06. FDA classified it as Class II and gives the reason as "Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1016-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-06
Posted: 2023-01-25
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.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
FDA 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 [email protected].
Quantity in commerce: 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
Product codes and lots: Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-25

Product code CEW

K000471Class IIFuture Diagnostics B.v. Stat-Intraoperative Intact Pth KitFuture Diagnostics B.V. / cleared 2000-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)