Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit Recalled by Siemens Healthcare Diagnostics Inc Due to Some v2.2.2 upgrade kits include a dialysate mode...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc directly.
Affected Products
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Quantity: 76
Why Was This Recalled?
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc has 75 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report