—#107856

Product

EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Catalog number 1000034805

Why it was recalled

QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Healthcare Diagnostic Inc, sent a Urgent Field Safety Notice dated December 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to follow these instructions. The first option is Extending the "Minimum Inactive Days" to 999 days. The second option is to proactively monitor the system for unexpected Pending QC Controls. Long Term Action Plan: A corrective and preventive action (CAPA) investigation has been issued. Currently firm is actively investigating. Further questions please call (302) 631-0516.

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 (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.

Timeline

Recall initiated: 2011-12-02
Posted by FDA: 2012-04-10
Terminated: 2014-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.