70%Confidence
0Views
FDASource
2026-04-07Date
Summary
Radnostix's Class III recall for failed capsule specifications in a diagnostic kit poses lower health risks but reflects manufacturing inconsistencies. This may lead to minor operational disruptions and increased quality monitoring costs for the company.
Actionable: Assess Radnostix's manufacturing processes to ensure compliance with diagnostic kit standards.
AI Confidence: 70%
Data Points
firmRadnostix
classificationClass III
statusOngoing
distributionNationwide in the US, including Puerto Rico
productGelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, Internation
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