—#128863

Product

Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K130276
Affected lot / code info: All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338

Why it was recalled

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide and internationally, including Canada and Mexico

Timeline

Recall initiated: 2014-07-16
Posted by FDA: 2014-08-26
Terminated: 2014-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.