Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk
Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a manufacturing defect in analyzer valves. No illnesses or injuries have been reported; the hazard is potential (valve wear and leaking over time may impact test accuracy).
Plain-English summary
The FDA has issued a Class II recall for valves used in Siemens Healthcare Diagnostics' Atellica CH 930 Analyzer, a medical device for in vitro diagnostic testing. The analyzer is distributed in the United States (210 units) and internationally (874 units) across more than 50 countries.
The affected valves may develop a malfunction due to a manufacturing defect and may wear and leak over time. Valves subject to high pressure or high-wear conditions are at particular risk. Leaking from these valves could impact the accuracy of diagnostic test results.
Healthcare facilities and clinical laboratories using Atellica CH 930 Analyzers should verify whether their equipment serial numbers fall within the affected range (CM00902 to CM02065). Facilities with potentially affected devices are advised to contact Siemens Healthcare Diagnostics for further guidance.
The recalled product
- Product
- Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- manufacturing-defect
- valve-malfunction
- accuracy-impact
Distribution
Distributed nationwide across the United States.
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