Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diag

FDA device recall Z-1454-2012 · posted 2012-04-25 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations

Action taken

Siemens sent an Urgent Field Safety Notice dated December 19, 2011 to all affected customers alerting them to Invalid Below Manufacturer Assay Range Flags on Dimension Vista(R) Systems with Software Version 3.4. The UFSN included instructions on how to correct the situation and also included an effectiveness check form to be faxed to the firm at 302-631-8467. On January 16, 2012, the firm issued an additional UFSN alerting consignees to Invalid Above and Below Manufacturer Assay Range Flags. This notice also included directions and a Field Correction Effectiveness Check form to be completed and faxed to 302-631-8467. For technical questions customers were instruced to call 800-441-9250. For questions regarding this recall call 302-631-6299.

Root cause

Software change control

Status

Terminated

Product code

JJE

Quantity affected

1,683

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland & Baltics, France, Germany, Italy, Japan, South Korea, Malaysia, Ne

Date initiated

2012-01-16

Date posted

2012-04-25

Date terminated

2014-03-05

Location

Newark, DE

Related 510(k) clearances