Z-1867-2014Class II

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

Name: Z-1867-2014 Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-10-11 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory on 2012-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1867-2014
Classification: Class II
Status: Terminated
Initiated: 2012-10-11
Posted: 2014-06-25
Terminated: 2014-08-26
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1867-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1867-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)