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

Recall Z-2114-2013 — ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.

U.S. FDA — Device Enforcement · United States · 2013-06-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2114-2013
Date of alert
2013-06-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10360958
Reported risk: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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