Recalls / —
—#116505
Product
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). 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
- Affected lot / code info
- Siemens Material Number 106393377
Why it was recalled
Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2013-02-27
- Posted by FDA
- 2013-04-01
- Terminated
- 2014-01-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #116505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.