Z-1017-2010

Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic

Name: Z-1017-2010 Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-06-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-06-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic on 2009-06-16. The reason FDA records is "Incorrect result: patient sample BUN results reported may be higher or lower than actual level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1017-2010
Status: Terminated
Initiated: 2009-06-16
Posted: 2010-03-08
Terminated: 2010-11-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
Root cause tag: manufacturing process
FDA 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 in commerce: 1254 cartons
Distribution: Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
Product codes and lots: Lot number 09061AA exp 2010-03-02

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)