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

Hazard

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

Details from the source

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 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) Lot/code info: Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.

UPC codes

00842768015694

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.