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

Hazard

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

Details from the source

Reason for recall: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay 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 Quantity: 342 kits Lot/code info: Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636

UPC codes

08719326045214

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.