Dimension Vista V-LYTE Standard A, Catalog No K820 recallZ-0139-2011 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 19, 2010
Terminated All recalls posted in October 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
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0139-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 19, 2010
- Posted by the FDA
- Oct 25, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3,706 cartons
- Product code
- CEM
- FDA submissions
- K051087
- Distribution
- USA, Nationwide Distribution
Product description
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Code information (models, lots, serial numbers)
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
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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