Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
FDA Recall Z-1017-2010 · Posted 2010-03-08
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2009-06-16
Date Terminated2010-11-30
Product Quantity1254 cartons
Reason for Recall
Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.