FDAFDA · Food and drugs·Recall number Z-0509-2013
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Published December 19, 2012 · Recall initiated: November 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
- Lot
- All lot codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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