Siemens ADVIA Centaur XP Immunoassay System Recalled for Gas Spring Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay systems because gas springs may fail, causing the instrument cover to fall.
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 3/5 (High).
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. The hazard involves a mechanical failure that could cause the instrument cover to fall, posing a risk of injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. The recall involves 5,900 units, including 1,679 units distributed domestically and 4,221 units distributed internationally. The affected products include the ADVIA Centaur XP (Catalog # 078-A011-03) and the ADVIA Centaur XP refurb (Catalog # 078-A011R03).
The recall is due to a defect in the instrument cover gas springs. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This failure may lead to the cover falling.
The recall is classified as Class II by the FDA. Siemens Healthcare Diagnostics is the recalling firm. Users of these devices should contact the manufacturer for instructions on how to address the defect.
The recalled product
- Product
- ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
- Manufacturer
- Siemens Healthcare Diagnostics
Distribution
Distributed nationwide across the United States.
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