Recall Z-1867-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
| Date | Jun 25, 2014 (initiated Oct 11, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 saf |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.