Alinity c Iron Reagent Recalled for Falsely Elevated Test Results
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
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 with no reported illnesses or injuries. The hazard is theoretical but significant: falsely elevated lab results could affect clinical decision-making for affected patients.
Plain-English summary
The FDA is recalling Alinity c Iron Reagent, Reference Number 08P3920, manufactured by Sentinel CH SpA. The affected lots are 21046Y600, 21118Y600, 30227Y600, and 30302Y600. Approximately 4400 kits have been distributed nationwide. This reagent is used on Abbott Alinity Instruments to measure iron levels in patient samples.
Internal testing confirmed that the affected lots produce elevated iron assay results. Results from affected lots have shown values up to 15% higher than expected. Additionally, quality control testing with affected lots may fail to meet proper standards, potentially delaying the reporting of patient results.
The combination of falsely elevated results and potential delays in quality control verification could impact clinical decision-making based on patient iron measurements. No illnesses or injuries have been reported.
Healthcare facilities and clinical laboratories using these specific lot numbers should stop using them immediately. Contact Sentinel CH SpA or Abbott for replacement reagent. Facilities should review any patient results generated with the affected lot numbers.
The recalled product
- Product
- Alinity c Iron Reagent, Reference Number 08P3920
- Manufacturer
- Sentinel CH SpA
- Hazard
- inaccurate-lab-results
- quality-control-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 (5)
- UDI-DI: 00380740136253
- Lot Number: 21046Y600
- 21118Y600
- 30227Y600
- 30302Y600
Distribution
Distributed nationwide across the United States.
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