Future Diagnostics Solutions B.V.: Medical Device Recall in 2023 - (Recall #: Z-1016-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 6, 2022

Date Posted: February 1, 2023

Recall Number: Z-1016-2023

Event ID: 91344

Reason for Recall:

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

Status: Ongoing

Product Quantity: 342 kits

Code Information:

Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated