Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.

FDA Recall Z-1516-06 · Posted 2006-09-23

Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2006-08-04
Date Terminated2012-07-30
Product QuantityDomestic - 101, Foreign - 153

Reason for Recall

Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank

Firm Action

On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.

Root Cause

Software design

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971418CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZERChiron Diagnostics Corp. · 1997-07-17

Official Source

View FDA Recall →

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

↑