UnratedMedical device recall · FDA · Published August 8, 2023
Siemens ADVIA Iron_2 Reagents May Cause False High Results in Lab Tests
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 ADVIA Iron_2 Reagents May Cause False High Results in Lab Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57516-siemens-advia-iron-2-reagents-may-cause-false-high-results. Based on FDA recall #Z-2666-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2666-2023%22&limit=1).
The FDA announced on August 8, 2023, that Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Iron_2 (IRON_2) Reagents due to a potential positive bias in quality control and patient sample results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: ADVIA Chemistry Iron_2 (IRON_2) Reagents
Material Numbers: 10377510, 10341118
Lot Numbers: 612584, 625096, 612579, 625091, 635826, 635821
The hazard
According to the FDA, there is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. The observed bias will vary from wedge to wedge when the issue occurs.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Recent brand recalls include the Siemens Atellica CH RCRP Test recall from August 17, 2026, and the Siemens Atellica CH Urine Albumin Recall from July 6, 2026. Other recent recalls of similar products include the Diagnostica Stago Asserachrom HPIA Kit Recall (December 15, 2025), the Beckman Coulter Bicarbonate Reagent recall (October 14, 2025), and the Magellan LeadCare II Blood Lead Test Kits recall (March 13, 2026).
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Kit Details
Identify the material number and lot number on the reagent kit to see if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide. Global Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
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-2666-2023 (August 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2666-2023 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.