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.
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 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…
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- HighSiemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias
FDA (Devices) · 2014-09-24
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- LowSiemens ADVIA Centaur CP Immunoassay System Recalled for Documentation Errors
FDA (Devices) · 2016-05-18
- LowSiemens Recalls ADVIA Centaur BNP Assay Reagents Due to Labeling Error
FDA (Devices) · 2014-11-26
- HighSiemens ADVIA Centaur XPT Immunoassay System Recall for Maintenance Setting Error
FDA (Devices) · 2016-10-19
- ModerateSiemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues
FDA (Devices) · 2017-05-24