FDA Device recall Z-2228-2012
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) ass…
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) ass… by Siemens Healthcare Diagnostics, citing syphilis Assay Interference with HBsAg Assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-17 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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
Reason
Syphilis Assay Interference with HBsAg Assay
Identifiers
| code_info | US Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2012%22
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