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.
Sentinel CH SpA is recalling two specific iron assay kits that could produce false elevated results or delay patient test reports. This affects laboratory use where these kits are used with Abbott instruments.
The recalled kits can cause false elevated iron results and delayed patient reports when used in certain laboratory settings. This happens because the kits show a positive shift in quality control and patient samples, leading to inaccurate test outcomes.
Laboratories using Sentinel CH SpA's iron assay kits with Abbott Alinity or Architect instruments may be affected. Those handling the specific reference numbers listed are most at risk.
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.
Identify if your kit has reference numbers 6K95-41 or 6K95-30.
The recall is due to potential false elevated iron results and delayed patient reports when using the affected kits with Abbott instruments.
Check the reference numbers on your kits. If they match the recalled numbers, contact Sentinel CH SpA for guidance.
The recall addresses potential inaccurate test results and delays in reporting, not direct safety risks to users.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-0325-2024 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-0325-2024 from Sentinel CH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
