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.
This recall has been terminated (originally issued May 13, 2014).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- February 18, 2014
- Posted
- May 13, 2014
- Terminated
- March 6, 2017
- Recall Number
- Z-1553-2014
- Quantity
- 5,900 units total (1,679 domestically & 4,221 internationally)
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and internationally
Lot / Code Info
All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Root Cause
Device Design
Action Taken
On February 18, 2014 Siemens Healthcare Diagnostics distributed Urgent Medical Device Correction notices to their customers via courier service (Urgent Medical Device Correction/). Upon receipt of the communication, customers are asked to follow "Actions to be Taken by the Customer". If the cover is unable to stay partially raised, immediately contact your Siemens technical support representative to arrange for a service. Complete and return the Field Correction Effectiveness Check attached to this letter within thirty (30) days by faxing to (302) 631-7597. Customers with questions should contact their Siemens technical support representative.