CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Atellica CH Diluent - CONS .; Siemens Material Number (SMN) recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent - CONS .; Siemens Material Number (SMN): 11099300, distributed nationwide in the US. The recall was initiated on 22 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2027-2025
- FDA event ID
- 96952
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 25 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 22 May 2025 | Recall initiated by company | |
| 25 Jun 2025 | Classified by FDA | +34 days |
| 2 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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