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ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended fo...

FDA Device Recall #Z-2716-2014 — Class II — August 19, 2014

Recall Summary

Recall Number Z-2716-2014
Classification Class II — Moderate risk
Date Initiated August 19, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics
Location Tarrytown, NY
Product Type Devices
Quantity Domestic: 2771 units; Foreign: 7744 units

Product Description

ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

Reason for Recall

The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full

Distribution Pattern

Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.

Lot / Code Information

All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899

Other Recalls from Siemens Healthcare Diagnostics

Recall # Classification Product Date
Z-0827-2018 Class II BC Thrombin Reagent Kit Lot Number 46751; UDI -... Oct 17, 2017
Z-0122-2015 Class II IMMULITE /IMMULITE 1000 Systems COR Cortisol, R... Sep 19, 2014
Z-2715-2014 Class II ADVIA Centaur Immunoassay System (including ref... Aug 19, 2014
Z-2662-2014 Class II ADVIA Centaur Immunoassay System, Catalog Numbe... Aug 13, 2014
Z-2663-2014 Class II ADVIA Centaur XP Immunoassay System, Catalog Nu... Aug 13, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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