Dimension Vista(R) MG Flex(R) Reagent Cartridge recallZ-1433-2012 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 17, 2012
Terminated All recalls posted in April 2012
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
Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.
Recall details
- Recall number
- Z-1433-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2012
- Posted by the FDA
- Apr 17, 2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 9,178
- Product code
- JGJ
- FDA submissions
- K061655
- Distribution
- Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
Product description
Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
Code information (models, lots, serial numbers)
Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
Other devices under the same FDA submission
6 devices cleared under K061655 — 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 VANC 10445128Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, VANCOMYCIN13 reports
- Dimension Vista® Flex® reagent cartridge ACTM 10445110Siemens Healthcare Diagnostics Inc. · COLORIMETRY, ACETAMINOPHEN2 reports
- Dimension Vista® Flex® reagent cartridge CHOL 10445143Siemens Healthcare Diagnostics Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL1 report
- Dimension Vista® Flex® reagent cartridge SAL 10445108Siemens Healthcare Diagnostics Inc. · COLORIMETRY, SALICYLATE1 report
- Dimension Vista® Flex® reagent cartridge GLU 10445162Siemens Healthcare Diagnostics Inc. · HEXOKINASE, GLUCOSE1 report
- Dimension Vista® Flex® reagent cartridge PHOS 10445144Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
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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