70%Confidence
0Views
FDASource
2026-04-11Date
Summary
Radnostix's Class III recall for a Sodium Iodide I-131 kit due to failed specifications involves a niche diagnostic product, posing minimal market impact but highlighting quality lapses. This may affect small-scale nuclear medicine operations and require replacement sourcing.
Actionable: Verify the availability of alternative I-131 kits for medical facilities to avoid diagnostic delays.
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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