FDA Device recall Z-1016-2023
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic by Future Diagnostics Solutions B V, citing due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1016-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-06 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Future Diagnostics Solutions B V |
| Distribution | AZ, CA, CO, LA, OH, PA, TX |
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Reason
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Identifiers
| code_info | Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1016-2023%22
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