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

Recall Z-2662-2014 — ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008,

U.S. FDA — Device Enforcement · United States · 2014-08-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2662-2014
Date of alert: 2014-08-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10284980

Reported risk: The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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