Atellica CH Diluent Contaminated with Sodium Hypochlorite
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The contamination poses a risk to laboratory test accuracy but is being addressed through a precautionary recall with specific guidance for remediation.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Diluent - CONS 2 x 1.5L (Siemens Material Number 11099300, UDI-DI: 00630414595771) because the product has been contaminated with sodium hypochlorite (NaOCl). This contamination may impact calibrator, quality control (QC), and patient results for all assays except those measuring sodium, potassium, and chloride.
The affected lot number is 0000195412. A total of 1,625 units have been distributed: 1,450 units in the United States and 175 units outside the US in Canada and the Bahamas.
Healthcare facilities and laboratories using this product should discontinue use and contact Siemens Healthcare Diagnostics for instructions on replacement or verification of affected test results. Facilities should review any results generated with the contaminated diluent for assays other than sodium, potassium, and chloride tests.
The recalled product
- Product
- Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number (SMN): 11099300
- UDI-DI: 00630414595771
- Lot Number: 0000195412
Distribution
Distributed nationwide across the United States.
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