CLASS III Device recall · Reported 26 Nov 2014 · FDA Enforcement Report
Advia Centaur¿ and Advia Centaur¿ XP recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur¿ and Advia Centaur¿ XP and Advia Centaur¿ CP Cleaning Solution (For in, distributed nationwide in the US. The recall was initiated on 12 Sep 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0214-2015
- FDA event ID
- 69282
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Sep 2014
- FDA classified
- 14 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Sep 2014 | Recall initiated by company | |
| 14 Nov 2014 | Classified by FDA | +63 days |
| 26 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability of the ADVIA Centaur Cleaning Solution is not assured
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
Questions about this recall
Why was it recalled?
Stability of the ADVIA Centaur Cleaning Solution is not assured
Which lots are affected?
Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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