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Terminated

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

FDA Recall Z-1615-2016 · Posted 2016-05-06

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2016-03-30
Date Terminated2017-03-29
Product QuantityUS: 442 units; Foreign: 3237 units

Reason for Recall

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

Firm Action

Siemens sent an Urgent Medical Device Correction letter dated March 2016, to all affected customers. The letter was sent to the US customers via Fed Ex beginning on March 30, 2016., and were e-mailed dated March 20, 2016, to regional countries for implementation outside the US. Field service personnel were sent a support bulletin describing the issue and instructing them how to manage customer questions. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please review this letter with your Medical Director. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (914) 524-2868.

Root Cause

Use error

Distribution Pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERBayer Healthcare, LLC · 2004-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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