FDAFDA · Food and drugs·Recall number Z-1537-2017
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results.
Published March 29, 2017 · Recall initiated: February 2, 2017
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
Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam.
- Lot
- All Serial Numbers; Software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656), V1.1 (Bundle 1.1.243 SMN 11221979, 11222064) and V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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