Recalls / —
—#84330
Product
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
- 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
- Lot number 09061AA exp 2010-03-02
Why it was recalled
Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.
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, Australia, Canada, Germany, Japan, and Korea.
Timeline
- Recall initiated
- 2009-06-16
- Posted by FDA
- 2010-03-08
- Terminated
- 2010-11-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #84330. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.