Recall Z-2553-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2553-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-16

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-07-16, terminated 2014-12-16. It names one FDA 510(k) clearance: K130276. Product: 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-16
Terminated: 2014-12-16
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K130276 — DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.·cleared 2013-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.