Sentinel CH recalls Alinity c Iron Reagent (REF 08P3920) due to potential false high iron results and delayed patient reports. Affected lots may cause inaccurate 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 is recalling Alinity c Iron Reagent (Reference Number 08P3920) because it can cause false high iron test results and delayed patient reports. This affects labs using the reagent with Abbott Alinity or Architect instruments.
The reagent can cause false high iron results in tests, up to 15% for Alinity c and 30% for Architect instruments. This may lead to delayed patient results due to quality control failures in the testing process.
Labs using Sentinel CH's Alinity c Iron Reagent (Reference Number 08P3920) with Abbott Alinity or Architect instruments are affected. Lab technicians and patients who receive test results from these devices are most at risk.
Check for the reagent reference number 08P3920 on the product label. Affected lots include 21046Y600, 21118Y600, 30227Y600, and 30302Y600. The product is sold by Sentinel CH.
Look for lot numbers 21046Y600, 21118Y600, 30227Y600, or 30302Y600 on the product label.
The reagent can cause false high iron results and delayed patient reports due to quality control failures.
The recall record does not specify a remedy, so contact Sentinel CH for guidance.
The reagent is used with Abbott Alinity and Architect instruments.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-0326-2024 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-0326-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
