Siemens Dimension Vista(R) System Vista Drug 4 Calibrator.… recallZ-1151-2013 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 21, 2013
Class II Terminated All recalls posted in April 2013
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
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
FDA root cause category: Process control
What the company is doing
The firm initiated their recall of this product by sending an Urgent Medical Device Recall letter dated February 2013 to all Dimension Vista Drug 4 Calibrator customers who received the affected lots. The letter notified them of the issue, the potential risk to health, and actions to be taken by customers.
Recall details
- Recall number
- Z-1151-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 21, 2013
- Posted by the FDA
- Apr 18, 2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1,638
- Product code
- KXT
- FDA submissions
- K093441, K112142
- Distribution
- Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product description
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Code information (models, lots, serial numbers)
Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.
Other devices under the same FDA submission
1 device cleared under K093441, K112142 — 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® Flex® reagent cartridge DIGXN 10488927Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, DIGOXIN15 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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