Intraoperative PTH Test Kits Recalled Due to High Result Variability
Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is analytical variability in test results, a quality defect but without documented adverse patient outcomes. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is 3; the Class II classification and absence of harm reports support a Moderate rating.
Plain-English summary
Future Diagnostics Solutions B.V. has issued a recall of STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kits (catalog number 4K-IPT-00, UDI-DI 08719326045214-230915). These kits are used to measure parathyroid hormone (PTH) levels during intraoperative settings.
The recall was initiated due to a high coefficient of variability (CV) problem caused by accuspheres inside the immunoassay kits. This issue affects the reliability and accuracy of PTH measurement results.
Approximately 342 kits were distributed worldwide, including locations in the United States (Arizona, California, Colorado, Louisiana, Ohio, Pennsylvania, and Texas) and multiple European countries (Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom). The affected lot numbers are M78559, M78560, and M78636.
No specific remedial actions for end users are provided in the official recall notice. Healthcare facilities and laboratories using these kits should contact Future Diagnostics Solutions B.V. for guidance on next steps.
The recalled product
- Product
- Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- Manufacturer
- Future Diagnostics Solutions B.V.
- Affected units
- 342
Distribution
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