Future Diagnostics STAT-IntraOperative-Intact-PTH — Class II medical device recall Z-1016-2023
Ongoing recall by Future Diagnostics Solutions B.V., reported 2023-02-01, distributed in AZ, CA, CO, LA, OH, PA, TX. Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoass
| Recall number | Z-1016-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Future Diagnostics Solutions B.V., Wijchen, N/A, Netherlands |
| Recall initiated | 2022-12-06 |
| Classified | 2023-01-25 |
| Reported by FDA | 2023-02-01 |
| Distributed | AZ, CA, CO, LA, OH, PA, TX |
| Countries outside the US | AT, DE, DK, ES, FR, GB, GR, IE, IT, NL, SE |
| Quantity | 342 kits |
| Lot numbers | M78559, M78560, M78636 |
| Model numbers | 4K-IPT-00 |
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Reason for recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1016-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.