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

Recall Z-2553-2014 — Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.

U.S. FDA — Device Enforcement · United States · 2014-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2553-2014
Date of alert
2014-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10636929
Reported risk: The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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