CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report
Advia Centaur HCY Diluent recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Advia Centaur HCY Diluent, distributed nationwide in the US. The recall was initiated on 25 Jun 2013 and the FDA has classified it as Class II.
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-1960-2014
- FDA event ID
- 65562
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2013
- FDA classified
- 2 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2013 | Recall initiated by company | |
| 2 Jul 2014 | Classified by FDA | +372 days |
| 9 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Product as listed by the FDA
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
Questions about this recall
Why was it recalled?
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Which lots are affected?
Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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