Lower riskMedical device recall · FDA · Published May 22, 2025
Siemens Atellica CH Diluent Recall: Contamination Risk for Lab Tests
Siemens Healthcare recalls Atellica CH Diluent (SMN 11099300) due to sodium hypochlorite contamination that may affect lab test results. Affected units include specific lot numbers and sizes.
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
“Siemens Atellica CH Diluent Recall: Contamination Risk for Lab Tests.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52239-siemens-atellica-ch-diluent-recall-contamination-risk-for-lab-tests. Based on FDA recall #Z-2027-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2027-2025%22&limit=1).
The FDA announced on May 22, 2025, that Siemens Healthcare Diagnostics is recalling Atellica CH Diluent due to sodium hypochlorite contamination. This defect may impact calibrator, quality control, and patient results for all assays except sodium, potassium, and chloride.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Diluent - CONS 2 x 1.5L
Siemens Material Number (SMN): 11099300
UDI-DI: 00630414595771
Lot Number: 0000195412
The hazard
The diluent is contaminated by sodium hypochlorite (NaOCl). This contamination may impact calibrator, quality control, and patient results for all assays except for sodium, potassium, and chloride.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Spectra Medical Devices Sodium Chloride Injection Recall (July 6, 2026), HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (Nov. 18, 2025), and Hologic ThinPrep CytoLyt Solution Recall (Dec. 12, 2025).
How to tell if you have this one
Check for the Siemens Material Number (SMN) 11099300 on the product label. The affected units are 2 x 1.5L containers with lot number 0000195412.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the Siemens Material Number (SMN) 11099300 and lot number 0000195412 on the Atellica CH Diluent container.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.” 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 41 days 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-2027-2025 (May 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2027-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.