Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IRON assay Recalled by Sentinel CH SpA Due to A high recovery of Iron assay has been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sentinel CH SpA directly.
Affected Products
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Quantity: 4394 kits
Why Was This Recalled?
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sentinel CH SpA
Sentinel CH SpA has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report