Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
FDA device recall Z-1016-2023 · posted 2023-01-25 · Open, Classified
Recall details
- Recalling firm
- Future Diagnostics Solutions B.V.
- Reason for recall
- Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CEW
- Quantity affected
- 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
- Date initiated
- 2022-12-06
- Date posted
- 2023-01-25
- Location
- Wijchen, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT (K000471) | Future Diagnostics B.V. | 2000-04-11 |