CLASS II Device recall · Reported 29 Aug 2012 · FDA Enforcement Report
Siemens Advia Centaur¿ Syphilis (Syph) Assay recalled
Siemens Healthcare Diagnostics is recalling Siemens Advia Centaur¿ Syphilis (Syph) Assay , 200 ReadyPack Reference Number 10492493, distributed nationwide in the US. The recall was initiated on 17 Jul 2012 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-2228-2012
- FDA event ID
- 62640
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2012
- FDA classified
- 20 Aug 2012
- Reported
- 29 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jul 2012 | Recall initiated by company | |
| 20 Aug 2012 | Classified by FDA | +34 days |
| 29 Aug 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Syphilis Assay Interference with HBsAg Assay
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
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
Questions about this recall
Is Siemens Advia Centaur¿ Syphilis (Syph) Assay , 200 ReadyPack Reference Number 10492493 recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Advia Centaur¿ Syphilis (Syph) Assay , 200 ReadyPack Reference Number 10492493 on 17 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2228-2012.
Why was it recalled?
Syphilis Assay Interference with HBsAg Assay
Which lots are affected?
US Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003 2012-10-13; 90054004 2013-04-09; 90422004 2013-04-09. Outside the US: Kit lots, 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003,88440003,90054004,90422004.
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand 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 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 21 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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