Siemens Atellica Analyzer Software Recall for Diagnostic Errors
Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.
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: The recall is classified as FDA Class II. The identified issues are software behavioral errors that may lead to incorrect diagnostic results or sample handling errors, but the source text does not report any hospitalizations, serious injuries, or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 115 units of the Atellica CH 930 Analyzer (SMN 11067000) and related Atellica Solution systems. The recall affects software version 1.13 and lower. The Atellica Solution is a multi-component system used for in vitro diagnostic testing of clinical specimens.
The recall was initiated because five behavioral issues were identified in the software. These issues include: the Reagent Lock may not function correctly when multiple lots of specific reagent kits are loaded; sample barcodes may be read incorrectly; the Atellica IM 1300 and 1600 Analyzers may fail to run specific Carcinoembryonic Antigen (CEA) dilutions and may post a Sample Integrity Error; the Atellica CH 930 Analyzer may continue to display default reporting units after they have been changed; and the Atellica CH 930 Analyzer may fail to display results for samples if certain assays are configured to auto-dilute results outside the measuring interval.
The affected units were distributed nationwide and in foreign countries including Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Republic Korea, Singapore, Spain, Sweden, Switzerland, U.A.E., and the United Kingdom. Users of the affected software should contact Siemens Healthcare Diagnostics for instructions on updating the software or resolving the identified issues.
The recalled product
- Product
- Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 115
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 (SW) version 1.13 and lower
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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