Lower riskMedical device recall · FDA · Published September 29, 2023
Sentinel CH SpA Recalls Iron Assay Kits for Potential False Results
Sentinel CH SpA recalls two iron assay kits (reference numbers 6K95-41 and 6K95-30) due to potential false elevated results and delayed patient reports. Affected kits may cause inaccurate blood test results.
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.
Take action
Contact the company
📍Recalling firmSentinel CH SpAVia Robert Koch 2 · Milan, Italy
“Sentinel CH SpA Recalls Iron Assay Kits for Potential False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57203-sentinel-ch-spa-recalls-iron-assay-kits-for-potential-false. Based on FDA recall #Z-0325-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0325-2024%22&limit=1).
Sentinel CH SpA recalled its IRON assay, Reference Numbers 6K95-41 and 6K95-30, due to potential falsely elevated results, the FDA announced on Sept. 29, 2023. The recall affects 4,394 kits distributed worldwide.
How to tell if you have it
Brand: Sentinel CH
Product: IRON assay
Reference Number 6K95-41: UDI-DI 00380740010928; Lot Number 30610Y600
Reference Number 6K95-30: UDI-DI 00380740010911; Lot Numbers 21058Y600, 21101Y600, 30918Y600
Quantity: 4,394 kits
The hazard
Internal studies confirmed a positive shift in Quality Control and patient sample results, up to 15% for Alinity c Iron Reagent and up to 30% for Architect Iron Products. Using affected lots may cause QC failures that delay reporting or result in falsely elevated patient values.
Context
GovInfoNow's records show Sentinel CH SpA has issued three other recalls since June 28, 2019. On July 29, 2021, the company recalled an Alinity c CRP Vario Calibrator Kit due to incorrect labeling causing calibration failures. Other recent recalls of similar products include a Roche Elecsys Anti-TSHR Assay recall on Nov. 21, 2025, and an Immunotech Estrone RIA Kit recall on Dec. 15, 2025.
How to tell if you have this one
Check for reference numbers 6K95-41 or 6K95-30 on the kit. The kits were sold with specific lot numbers: 30610Y600 for 6K95-41 and 21058Y600, 21101Y600, 30918Y600 for 6K95-30.
Brand
Sentinel CH
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0325-2024
IRON assay, Reference Numbers 6K95-41 and 6K95-30; Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600
4394 kits
Z-0326-2024
Alinity c Iron Reagent, Reference Number 08P3920; UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600
4400 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Reference Numbers
Identify if your kit has reference numbers 6K95-41 or 6K95-30.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0325-2024 (September 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0325-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.