Recall Z-1016-2023 ยท CEW Radioimmunoassay, Parathyroid Hormone
Future Diagnostics Solutions B.V.
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
| Date | Jan 25, 2023 (initiated Dec 6, 2022) |
| Status | Open, Classified |
| Reason | Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. |
| Root cause | Under Investigation by firm |
| Action | 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 provide |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000471 | FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT Future Diagnostics B.V., Apr 11, 2000 |