Siemens Healthcare Diagnostics, Inc. Recall 95751
Description: Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare Diagnostics, Inc. Recall 95751 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0767-2025 |
| Event ID | 95751 |
| Event Description | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain. |
| Quantity | 13,115 units (11,520 US, 1,595 ROW) |
| Recall 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 patient s results are incorrect, and the results may be reported out |
| Device Classification | 20250101 |
| Device Code Info | Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC. |
| Center Classification Date | 20241226 |
| Recall Initiation Date | 20241112 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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