Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- Recall Initiated
- December 6, 2022
- Posted
- January 25, 2023
- Recall Number
- Z-1016-2023
- Quantity
- 342 kits
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
Lot / Code Info
Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Root 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.