Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
FDA device recall Z-1017-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1254 cartons
- Distribution
- Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
- Date initiated
- 2009-06-16
- Date posted
- 2010-03-08
- Date terminated
- 2010-11-30
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |