Recall Z-2228-2012— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2228-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2012-07-17, terminated 2013-11-22. It names one FDA 510(k) clearance: K112343. 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.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Terminated: 2013-11-22
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics, Inc.·cleared 2012-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Syphilis Assay Interference with HBsAg Assay

Data sourced from openFDA. This site is unofficial and independent of the FDA.