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All product recalls associated with Siemens Healthcare Diagnostics, Inc..
Total Recalls
475
Past Year
37
Class I (Serious)
6
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150