IRON assay kits recalled for inaccurate diagnostic results
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for diagnostic assay with potential for falsely elevated patient results up to 30% error. No reported injuries or illnesses; the hazard is theoretical, but this is a risk-of-harm product where diagnostic inaccuracy could impact clinical decisions, meeting the rubric criterion for high-risk diagnostics without reported harm.
Plain-English summary
Sentinel CH SpA is recalling IRON assay kits with Reference Numbers 6K95-41 and 6K95-30 designed for use with Abbott Architect instruments. These products have been distributed nationwide in the United States and worldwide.
A high recovery of iron in assay results has been observed at some customer sites. Internal quality control testing confirmed that affected lots produce falsely elevated iron measurements, up to 30% higher than actual values. When these affected lots are used, there is potential for delay in patient result reporting due to quality control failures, and potential for falsely elevated results that could impact patient care.
Clinical laboratories currently using the affected lot numbers (30610Y600 for Reference 6K95-41; 21058Y600, 21101Y600, 30918Y600 for Reference 6K95-30) should discontinue use immediately and contact Sentinel CH SpA for replacement kits. Patients whose test results were obtained from affected lots should be notified and retested as clinically appropriate using non-recalled products.
The recalled product
- Product
- IRON assay, Reference Numbers 6K95-41 and 6K95-30
- Manufacturer
- Sentinel CH SpA
- Hazard
- diagnostic-inaccuracy
- false-elevated-results
- qc-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Reference Number 6K95-41: UDI-DI: 00380740010928
- Lot Number: 30610Y600
- Reference Number 6K95-30: UDI-DI: 00380740010911
- Lot Numbers: 21058Y600
- 21101Y600
- 30918Y600
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27