Atellica IM 1300 Analyzers Incompatible with Software Can Produce Erroneous Thyroid Results
Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.
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: Score 3 applies because this is a risk-of-harm medical device where software incompatibility can generate incorrect diagnostic results that could affect patient care. No illnesses, injuries, or hospitalizations have been reported, and the hazard is potential rather than actual.
Plain-English summary
The FDA is alerting laboratory professionals and healthcare facilities about a recall of 1,566 Siemens Atellica IM 1300 Analyzers distributed worldwide. These automated diagnostic analyzers are used to perform immunoassay tests on clinical specimens in laboratory settings.
Certain product lots are incompatible with Test Definition (TDef) version 1.4 software, which can cause the analyzer to generate erroneous total T3 test results. Incorrect T3 measurements could lead to misdiagnosis or inappropriate treatment decisions for thyroid conditions.
The recall affects facilities using the affected product lots, which are identified by UDI 00630414007960. Affected laboratories and healthcare providers should immediately contact Siemens Healthcare Diagnostics for corrective action instructions and should not use the affected analyzers to report T3 test results until the software compatibility issue is resolved.
The recalled product
- Product
- Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- erroneous-results
- diagnostic-error
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 All lots
Distribution
Distributed nationwide across the United States.
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