Dimension Vista System BUN Flex Reagent Cartridge, Catalog… recallZ-1017-2010 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 16, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1017-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 16, 2009
- Posted by the FDA
- Mar 8, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1254 cartons
- Product code
- JJE
- FDA submissions
- K051087
- Distribution
- Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
Product description
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Code information (models, lots, serial numbers)
Lot number 09061AA exp 2010-03-02
Other devices under the same FDA submission
4 devices cleared under K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® 500 10284473Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall524 reports
- Dimension Vista® 500 Intelligent Lab System 10488217Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE13 reports
- Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- 10484429Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, POTASSIUM10 reports
- Dimension Vista® 1500 Intelligent Lab System 10459469Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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