ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP
FDA device recall Z-1553-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 5,900 units total (1,679 domestically & 4,221 internationally)
- Distribution
- Nationwide and internationally
- Date initiated
- 2014-02-18
- Date posted
- 2014-05-13
- Date terminated
- 2017-03-06
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |