Recalls / —
—#118790
Product
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended 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
- Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801
Why it was recalled
There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
Root cause (FDA determination)
Software design
Action the firm took
A notification letter was sent to consignees in May 2013.
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: USA (nationwide) and iinternationally to Canada.
Timeline
- Recall initiated
- 2013-05-20
- Posted by FDA
- 2013-12-02
- Terminated
- 2014-04-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.