Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 data integrity error in a diagnostic system, which is a significant functional defect but does not involve direct physical injury or high-risk biological contamination, fitting the Moderate category for low-risk functional issues.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur Immunoassay System, including refurbished units, due to a software issue affecting how patient demographic information is transmitted to Laboratory Information Systems (LIS). The recall covers 2,771 domestic units and 7,744 foreign units distributed worldwide.
The firm identified that under extremely rare circumstances, patient demographic data from a previous order may be merged with the next order. This issue occurs when the LIS data buffer on the ADVIA Centaur system becomes full. The system is intended for professional use in a laboratory environment for in vitro diagnostic testing.
Siemens has confirmed the issue and is conducting this recall to address the potential for data integrity errors. Users of the affected systems should contact Siemens Healthcare Diagnostics for further instructions on resolving the issue.
The recalled product
- Product
- ADVIA Centaur 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…
- 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 (20)
- All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980
- 10286140
- 10309524
- 10309525
- 10310210
- 10313282
- 10314322
- 10316248
- 10316372
- 10316968
- 10317060
- 10317403
- 10319111
- 10319433
- 10320929
- 10321568
- 10322149
- 10322731
- 10323204
- 10325015
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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