Siemens Healthcare Diagnostics, Inc. Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot number 09061AA exp 2010-03-02
Products Sold
Lot number 09061AA exp 2010-03-02
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. due to Incorrect result: patient sample BUN results reported may be higher or lower than actual level.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026