Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk
Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a mechanical defect (tubing crack) without reported injuries or illnesses in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur (including refurbished units) used for professional in vitro diagnostic tests in laboratories. The recall involves 10,515 units distributed nationwide, including Puerto Rico and all 50 states.
The recall is due to a potential defect where a slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. This issue is identified as an FDA Class II recall.
Healthcare facilities and laboratories should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to address the defect. The source text does not specify specific consumer actions beyond the manufacturer's recall process.
The recalled product
- Product
- ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 10,515
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)
- Product Codes: 10284980
- 10286140
- 10309524
- 10309525
- 10310210
- 10313282
- 10314322
- 10316248
- 10316372
- 10316968
- 10317060
- 10317403
- 10319111
- 10319433
- 10320929
- 10321568
- 10322149
- 10322731
- 10323204
- 10325015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. 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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