Recall Z-0214-2015— Siemens Healthcare Diagnostics, Inc
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-09-12, terminated 2015-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.. Reason: Stability of the ADVIA Centaur Cleaning Solution is not assured.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-09-12
- Terminated
- 2015-07-17
- Firm location
- East Walpole, MA, United States
Product description
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
Reason for recall
Stability of the ADVIA Centaur Cleaning Solution is not assured
Data sourced from openFDA. This site is unofficial and independent of the FDA.