—#127514

Product

Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K073604, K112999, K130276
Affected lot / code info: DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX

Why it was recalled

There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

Root cause (FDA determination)

Employee error

Action the firm took

An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.

Recalling firm

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

Distribution

Distribution pattern: FL LA AR IA OH OH WI IL LA KS MT

Timeline

Recall initiated: 2014-05-27
Posted by FDA: 2014-07-30
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127514. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.