Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2716-2014 — 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 b

U.S. FDA — Device Enforcement · United States · 2014-08-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2716-2014
Date of alert
2014-08-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10285219
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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