Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues
Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.
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, but the source text describes software behavioral issues without reporting any hospitalizations, significant injuries, or property damage, aligning with the Moderate severity criteria for low-risk or precautionary recalls.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 45 Atellica IM 1300 Analyzers (SMN 11066001) equipped with 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 is voluntary and is classified as Class II by the FDA.
The recall is due to five identified behavioral issues in the system software. First, the Reagent Lock may not function as intended when multiple lots of specific reagent kits are loaded simultaneously. Second, sample barcodes may be incorrectly read. Third, the Atellica IM 1300 and IM 1600 Analyzers may not run Carcinoembryonic Antigen (CEA) dilutions at 50x and 100x, potentially posting a Sample Integrity Error. Fourth, the Atellica CH 930 Analyzer may continue to display default reporting units after they have been changed. Fifth, the Atellica CH 930 Analyzer may not 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 23 foreign countries, including Australia, Canada, Germany, Japan, and the United Kingdom. No specific dates or lot numbers are provided in the source text. Users should contact Siemens Healthcare Diagnostics for instructions on software updates or remediation.
The recalled product
- Product
- Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 45
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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