Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
Siemens is correcting ADVIA Centaur 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 that may cause sample ID misreads, which is a low-risk contamination or labeling error without reported injuries, fitting the Moderate criteria.
Plain-English summary
Siemens Healthcare Diagnostics is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. The 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 sample rack loading instructions are not followed exactly as described in the Operators Guide, pushing the sample racks may cause misreads of Sample IDs (SID). The affected units are intended for professional use in a laboratory environment only for in vitro diagnostic use.
The field correction involves 10,515 units distributed worldwide, including 2,771 domestic units and 7,744 foreign units. The recall covers all serial numbers for the listed catalog numbers.
The recalled product
- Product
- ADVIA Centaur Immunoassay System, Catalog 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,
- Manufacturer
- Siemens Healthcare Diagnostics
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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