Siemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues
Siemens Healthcare Diagnostics is correcting ADVIA Centaur and XP systems where improperly loaded sample racks may cause sample ID misreads.
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 a field correction for a procedural issue (sample rack loading) that may cause data misreads, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. The recall involves 10,515 units distributed worldwide, including 2,771 in the United States. The systems are intended for professional use in laboratory environments for in vitro diagnostic testing.
The field correction addresses an issue where manually loaded sample racks may be improperly loaded or pushed too far on the sample entry queue during normal operation. If the sample rack loading instructions in the Operators Guide are not followed exactly, pushing the racks may cause misreads of Sample IDs (SID). The source text does not report any illnesses, injuries, or deaths associated with this issue.
This field correction affects laboratories using the affected systems. Siemens Healthcare Diagnostics is the recalling firm. The source text does not provide specific instructions for consumers or end-users, as the product is for professional laboratory use.
The recalled product
- Product
- ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnosti
- 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 (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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.
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