Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results
Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.
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 3/5 (High).
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 a Class II medical device recall involving a risk-of-harm product (clinical chemistry analyzer capable of producing diagnostic errors). No illnesses, injuries, or hospitalizations are reported in the source text, and the hazards remain theoretical. This meets the criterion for a High severity rating per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics is recalling approximately 2,980 units of the Atellica CH 930 clinical chemistry analyzer with software version V1.25.1 or lower. The analyzer has been distributed nationwide and internationally across numerous countries.
The recall was initiated due to two software defects. Test Definition parameters for Open Channel Assays may revert to default values rather than maintaining user-configured settings, which can shift test results by the magnitude of the configured Assay Correlation factor. Additionally, the On Board Stability feature may fail to update when manually changed, allowing the analyzer to continue using expired reagents when testing Open Channel Assays.
These defects present a risk that the analyzer may produce erroneous results when analyzing patient samples. Healthcare facilities and laboratories that use affected analyzers should contact Siemens Healthcare Diagnostics for corrected software versions or additional guidance.
The recalled product
- Product
- Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,980
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: V1.25.1 and lower. UDI: 00630414002163
Distribution
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