Siemens Healthcare recalls specific ADVIA Iron_2 reagent kits due to potential false high results in lab tests. Affected kits have material numbers 10377510 and 10341118. No remedy is stated in the recall notice.
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
Siemens Healthcare is recalling specific ADVIA Iron_2 reagent kits that may cause false high results in lab tests. This could lead to inaccurate patient results if the reagents are used without proper quality control checks.
The reagents may cause false high results in patient tests when used with certain wedge pairs. This variation in results could lead to incorrect diagnoses or treatment decisions if not detected through quality control checks.
Lab technicians and healthcare facilities using the recalled reagent kits may be affected. Those handling the kits without proper quality control checks are at higher risk.
Check for material numbers 10377510 (6 x 350 tests) or 10341118 (7 x 145 tests) on the reagent kits. The kits were sold with specific lot numbers: 612584, 625096, 612579, 625091, 635826, and 635821.
Identify the material number and lot number on the reagent kit to see if it matches the recalled items.
The reagents may cause false high results in patient tests, leading to inaccurate diagnoses if not detected through quality control checks.
Check for material numbers 10377510 (6 x 350 tests) or 10341118 (7 x 145 tests) and lot numbers 612584, 625096, 612579, 625091, 635826, or 635821.
The recall notice does not state any remedy or corrective action.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2666-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2666-2023 from Siemens Healthcare. 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.
