FDA recall Z-1016-2023

Future Diagnostics Solutions B.V. · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2022-12-06
Report date: 2023-02-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wijchen, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2023