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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Atellica CH Diluent Recalled for Sodium Hypochlorite Contamination

Agency Publication Date: June 25, 2025
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Summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,625 units (1,450 in the US and 175 internationally) of Atellica CH Diluent due to contamination with sodium hypochlorite (bleach). This contamination can interfere with laboratory testing and negatively impact the accuracy of results for nearly all assays, with the exception of sodium, potassium, and chloride tests. No injuries or incidents have been reported to date.

Risk

The presence of sodium hypochlorite in the diluent can lead to incorrect laboratory results for patients, quality controls, and calibrators. This could cause healthcare providers to make incorrect medical diagnoses or treatment decisions based on inaccurate data.

What You Should Do

  1. This recall involves Atellica CH Diluent (CONS 2 x 1.5L) identified by Siemens Material Number (SMN) 11099300 and Lot Number 0000195412. The UDI-DI is 00630414595771.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Siemens Healthcare Diagnostics, Inc., or your distributor to arrange for a return, replacement, or correction of the affected diluent.
  4. For additional information or to report concerns, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action for laboratory equipment.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Atellica CH Diluent - CONS 2 x 1.5L
Model / REF:
11099300
Lot Numbers:
0000195412
UDI:
00630414595771

Siemens Material Number (SMN): 11099300.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96952
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 1,625 units (1450 US, 175 OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.