Home / Recalls / Medical Devices
Future Diagnostics Solutions B.V. recalls Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Recalled February 1, 2023 · FDA recall Z-1016-2023 · Future Diagnostics Solutions B.V
Hazard
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. · FDA Class II
Units
342 kits
Sold at
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
Description
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Manufacturer(s)
Future Diagnostics Solutions B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →