Siemens Atelia IM 1300 Analyzer Recalled for Reporting Factor Errors
Siemens Healthcare Diagnostics is recalling Atelia IM 1300 Analyzers because reporting and conversion factors may not apply to all units when connected to a single solution system.
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, and the hazard involves potential reporting errors in diagnostic results without explicit reports of injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atelia IM 1300 Analyzer, a device used for in vitro diagnostic testing of clinical specimens. The recall was initiated because when more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
The affected units are identified by UDI 00630414007960. The distribution pattern includes Florida, France, Spain, Sweden, the United Kingdom, and Germany. The source text does not specify the total number of units affected or the specific dates of distribution.
Healthcare facilities and users of the Atelia IM 1300 Analyzer should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. The source text does not provide specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)
- UDI 00630414007960
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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