Z-0139-2011

Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista...

Name: Z-0139-2011 Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-08-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-19 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System on 2010-08-19. The reason FDA records is "High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0139-2011
Status: Terminated
Initiated: 2010-08-19
Posted: 2010-10-25
Terminated: 2010-10-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.
FDA root cause: Other
Action: Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.
Quantity in commerce: 3,706 cartons
Distribution: USA, Nationwide Distribution
Product codes and lots: KA0C03 EXP 3/24/11, KA0D01 EXP 4/14/11, KA0E01 EXP 5/5/11, KA0E02 EXP 5/19/11, KA0F01 EXP 6/3/11, AND KA0G01 EXP 7/8/11

Product code CEM

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)