Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error
Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.
What this means for you
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. The hazard involves a software error that delays result transmission and requires manual intervention, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Chemistry XPT System, specifically software version 1.0.2. The recall involves 16 units distributed in the United States (Arizona, California, and Washington) and internationally (Germany, Italy, Spain, and the United Kingdom). The affected software is identified by specific lot numbers and material numbers listed in the recall documentation.
The recall is due to a software defect that may cause samples to remain in an 'Inprocess' state. When this occurs, test results for those samples will not transmit to the Laboratory Information System (LIS). Manual intervention is required to complete the processing of samples held in this state.
Healthcare facilities using the affected software should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue and ensure proper sample processing.
The recalled product
- Product
- ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random
- 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 (17)
- Software Version 1.0.2
- Lot Numbers: CA1275000080008
- CA1275000090009
- CA1275000060006
- CA1275000050005
- CA1275000070007
- CA1275000130013
- CA1275000100010
- CA1275000120012
- CA1275000170017
- CA1275000260026
- CA1275000270027
- CA1275000280028
- CA1275000240024
- CA1275000200020
- CA1275000220022
- CA1275000410041
Distribution
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