Recall Z-1017-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
| Date | Mar 8, 2010 (initiated Jun 16, 2009) |
| Status | Terminated |
| Reason | Incorrect result: patient sample BUN results reported may be higher or lower than actual level. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1254 cartons |
| Distribution | Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |