Recall Z-1016-2023
Future Diagnostics Solutions B.V. · initiated December 6, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Codes / lots: Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Reason for recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
FDA-determined cause: Under Investigation by firm
Action taken
On 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV. As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result. Actions to be taken by customers: -Immediately identify and quarantine the affected lot numbers. -Further instructions will be provided by the Future Diagnostics. For questions, send an email to fieldsafety@future-diagnostics.nl.
Details
- Recall number
- Z-1016-2023
- Initiated
- December 6, 2022
- Posted by FDA
- January 25, 2023
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Quantity
- 342 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
- Recalling firm
- Future Diagnostics Solutions B.V., Wijchen