Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device

FDA device recall Z-0838-2015 · posted 2014-12-20 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

Action taken

An Urgent Medical Device Correction, dated November 2014, was issued on November 4th, 2014 to inform customers that Siemens Healthcare Diagnostics has confirmed that reagent probe performance on Dimension Vista systems may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. Instructions for replacing an associated reagent probe were provided to resolve the issue. Customers are to retain the letter for their laboratory records and forward it to anyone who has received the affected product. Customers are also to complete and return the Field Correction Effectiveness Check Form. Customer should direct their questions to their Siemens Customer Care Center - Technical Solutions at 1-800-441-9250 or their local Siemens technical support representative.

Root cause

Device Design

Status

Terminated

Product code

JJE

Quantity affected

1,949

Distribution

Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Sa

Date initiated

2014-11-05

Date posted

2014-12-20

Date terminated

2017-10-06

Location

Newark, DE

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