—#131351

Product

Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine 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: K051087
Affected lot / code info: Material Nos.: 10284473, 10488224, 10444801, and 10444802

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

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 -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.

Timeline

Recall initiated: 2014-11-05
Posted by FDA: 2014-12-20
Terminated: 2017-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131351. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.