Z-0980-2010

Dimension Vista LOCI Reaction Vessel

Name: Z-0980-2010 Dimension Vista LOCI Reaction Vessel
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-11-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-11-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista LOCI Reaction Vessel on 2009-11-24. The reason FDA records is "Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable". 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-0980-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-03-05
Terminated: 2011-09-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista LOCI Reaction Vessel
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
Quantity in commerce: 408 units
Distribution: The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.
Product codes and lots: Catalog number KS855. Lot number NH29-188-09

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)