Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 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, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1600 Analyzer, specifically units running software versions V1.19.0 and V1.19.2 (Siemens Material Number 11066000). The recall involves 166 total units, with 15 located in the United States and 151 distributed internationally to countries including Argentina, Australia, and the United Kingdom.
The recall was initiated due to issues with scanning new reagent lot test definitions on the Atellica IM 1300 and Atellica IM 1600 Analyzers. This defect may affect the proper identification or processing of reagent lots during testing.
Healthcare facilities and laboratories using these specific software versions should contact Siemens Healthcare Diagnostics for further instructions on remediation or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
- 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: 00630414002026
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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