Magnesium Flex reagent cartridge, 360 tests, Catalog… recallZ-0767-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 12, 2024
Open, Classified
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 Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
FDA root cause category: Nonconforming Material/Component
What the company is doing
On November 12, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Customer Actions Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Discontinue use of and discard the lots listed above. Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records and forward this letter to those who may have received the product. Resolution Siemens Healthineers has introduced additional manufacturing process controls that have resolved this issue. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Recall details
- Recall number
- Z-0767-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2024
- Posted by the FDA
- Dec 26, 2024
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,115 units (11,520 US, 1,595 ROW)
- Product code
- JGJ
- FDA submissions
- K140790
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.
Product description
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Code information (models, lots, serial numbers)
Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension Vista® Flex® reagent cartridge MG 10445158Siemens Healthcare Diagnostics Inc. · PHOTOMETRIC METHOD, MAGNESIUM1 recall5 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 16, 2026. Text above is shown as published by the FDA.
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