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🏥 FDA: Radnostix — Class III

healthcareneutralSource: FDA
70%Confidence
0Views
FDASource
2026-04-08Date

Summary

Radnostix's Class III recall for failed capsule specifications in a diagnostic kit suggests minor quality issues with limited immediate health risks. This is the least serious recall class but still indicates manufacturing process deviations that need correction.

Actionable: Monitor for any follow-up regulatory communications but consider this a low-impact event for the broader market.

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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