Wijchen, N/A, Netherlands
Future Diagnostics Solutions B.V. recalls
1 recall recorded since 2018, most recently on 6 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 December 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1016-2023
- Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.