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

FDA device recall Z-1867-2014 · posted 2014-06-25 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

The firm initiated their recall/correction of this product on October 11, 2012 by sending an Urgent Customer Notification letter to all StreamLAB(R) Automation Solutions customers. The letter informed customers that the firm received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module have contributed to two trip and fall incidents. Customers were advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution. Also, StreamLAB operators were to be notified of the potential safety issue and the notice was to be posted on or near the system. Additionally, customers were to complete and return the attached Field Correction Effectiveness Check form.

Root cause

Device Design

Status

Terminated

Product code

JJE

Quantity affected

317

Distribution

Nationwide Distribution -- AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

Date initiated

2012-10-11

Date posted

2014-06-25

Date terminated

2014-08-26

Location

Newark, DE