The Recall Desk
HighFDA (Devices)·Z-1553-2014·Announced 2014-05-14

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.

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. 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.

Distribution

Distributed nationwide across the United States.