Z-1016-2023 Class II Ongoing
FDA device recall Z-1016-2023 was initiated by Future Diagnostics Solutions B.V. on December 6, 2022 and is designated Class II. Reason for recall: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. The recall status is ongoing. Affected quantity: 342 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2023
- Initiation Date
- December 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 342 kits
Product Description
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 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
Code Information
Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636