Atellica CH 930 Analyzer photometer lamp may produce inaccurate results
Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.
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: This is an FDA Class II recall involving diagnostic inaccuracy—the photometer lamp may reach saturation without warning, generating incorrect patient test results that could lead to clinical misdiagnosis. No hospitalizations or illnesses have been reported to date, placing this at the 'risk-of-harm' level per the severity rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676, Siemens Material Number 11067000) due to a defect affecting laboratory diagnostic accuracy.
The photometer lamp in these devices may reach saturation without generating an alert or flag to the user. When saturation occurs, the analyzer may produce erroneously elevated or depressed patient test results without any warning to clinical staff.
Approximately 2,153 units have been distributed worldwide, including the United States and numerous other countries. Any laboratory using an affected device should immediately verify the software version (1.24.0 SP1 or lower) and contact Siemens Healthcare Diagnostics for instructions on correction or replacement. Laboratories should review recent patient results generated by affected analyzers and determine if retesting or result verification is warranted.
The recalled product
- Product
- Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- diagnostic-inaccuracy
- measurement-error
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 (1)
- Software version: 1.24.0 SP1 or lower
Distribution
Distributed nationwide across the United States.
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