FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
- Recall number
- Z-0767-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
- Status
- Open, Classified
- Initiated
- 2024-11-12
- Posted
- 2024-12-26
- Terminated
- not on file
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 13,115 units (11,520 US, 1,595 ROW)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.
- Lot, serial or model codes
- Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.
- 510(k) numbers
- ["K140790"]
- PMA numbers
- not on file
- Product code
- JGJ
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28