Magnesium Flex reagent cartridge recall
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Why was Magnesium Flex reagent cartridge 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.
- Product
- Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)