Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues
Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, placing this in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1300 Analyzer, specifically units running software versions V1.19.0 and V1.19.2. The recall is classified as Class II by the U.S. Food and Drug Administration. The issue involves problems with scanning new reagent lot test definitions on the analyzer.
A total of 88 units are affected by this recall. Of these, 54 units are located in the United States and 34 units are located outside the U.S. The affected devices were distributed nationwide in the U.S. and in various foreign countries, including Argentina, Australia, Bangladesh, Belgium, Brazil, Colombia, the Dominican Republic, Finland, France, Germany, Greece, Italy, Japan, Latvia, Mexico, the Netherlands, P.R. China, Republic Korea, Singapore, Spain, Switzerland, Thailand, the United Kingdom, and Vietnam.
The source text does not specify the exact corrective action required for consumers or healthcare facilities, nor does it report any specific injuries or illnesses associated with this defect. Users of the affected software versions should contact Siemens Healthcare Diagnostics for further instructions on how to resolve the scanning issue.
The recalled product
- Product
- Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
- 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)
- (SW) version V1.19.0 and V1.19.2 UDI: 00630414007960
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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