Z-0767-2025Class II

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158

Name: Z-0767-2025 Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-11-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-11-12 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158 on 2024-11-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0767-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-12
Posted: 2024-12-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Product code: JGJ Photometric Method, Magnesium
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-26

Product code JGJ

K140790Class IIDimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics / cleared 2015-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)