Recalls / —
—#93768
Product
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
- FDA product code
- JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K051087
- Affected lot / code info
- Part # 1000034805
Why it was recalled
the EasyLink QCFIRST custom rule does not operate as intended.
Root cause (FDA determination)
Other
Action the firm took
Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System. For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101
Distribution
- Distribution pattern
- Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.
Timeline
- Recall initiated
- 2010-07-23
- Posted by FDA
- 2010-10-21
- Terminated
- 2013-03-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #93768. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.