Dimension Vista LOCI Reaction Vessel recallZ-0980-2010 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 24, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0980-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 24, 2009
- Posted by the FDA
- Mar 5, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 408 units
- Product code
- JJE
- FDA submissions
- K051087
- 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 description
Dimension Vista LOCI Reaction Vessel
Code information (models, lots, serial numbers)
Catalog number KS855. Lot number NH29-188-09
Other devices under the same FDA submission
4 devices cleared under K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® 500 10284473Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall524 reports
- Dimension Vista® 500 Intelligent Lab System 10488217Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE13 reports
- Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- 10484429Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, POTASSIUM10 reports
- Dimension Vista® 1500 Intelligent Lab System 10459469Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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