FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
- Recall number
- Z-1867-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
- Status
- Terminated
- Initiated
- 2012-10-11
- Posted
- 2014-06-25
- Terminated
- 2014-08-26
- 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 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.
- 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28