Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.
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, but the source describes the hazard as occurring under 'extremely rare circumstances' and involves data integrity rather than direct physical injury or high-risk pathogen exposure, fitting the Moderate category for low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur XP Immunoassay System, including refurbished units, due to a software issue affecting patient demographic information. The system is intended for professional use in a laboratory environment for in vitro diagnostic testing.
The recall addresses a problem where patient demographic data from a previous order received from the Laboratory Information System (LIS) may be merged with the next order. Siemens has confirmed that this issue occurs under extremely rare circumstances when the LIS data buffer on the ADVIA Centaur system becomes full.
The recall covers 2,771 domestic units and 7,744 foreign units distributed worldwide, including the United States and numerous other countries. Affected units include all serial numbers with specific Model Numbers/Siemens Material Numbers (SMN) listed in the agency record. Users should contact Siemens Healthcare Diagnostics for further instructions on resolving this data integrity issue.
The recalled product
- Product
- ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical di
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
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)
- All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219
- 10316507
- 10317207
- 10317284
- 10319668
- 10320757
- 10323213
- 10324519
- 10327135
- 10327836
- 10328940
- 10329339
- 10336292
- 10338631
- 10364455
- 10388696
- 10471899
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics 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.
See all 2 products in this recall →Related recalls
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