Device 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.
Z-1553-2014
Product summary
- Event
- Event 67603
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,900 units total (1,679 domestically & 4,221 internationally)
- Official record key
device-enforcement:Z-1553-2014
Official wording
Reason: Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.
Code information: All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Distribution pattern: Nationwide and internationally
Derived failure modes
-
Unknown
Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.