Recall Z-1867-2014— Siemens Healthcare Diagnostics, Inc.

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-10-11, terminated 2014-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.. Reason: Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution..

Recalling firm
Siemens Healthcare Diagnostics, Inc.
Classification
Class II
Status
Terminated
Initiated
2012-10-11
Terminated
2014-08-26
Firm location
Newark, DE, United States

Product description

Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.

Reason for recall

Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.

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