Device product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Z-1016-2023
Product summary
- Event
- Event 91344
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 342 kits
- Official record key
device-enforcement:Z-1016-2023
Official wording
Reason: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay 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
Derived failure modes
-
Unknown
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.