Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is…

Recall date

July 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2601-2016

FDA classification

Class III

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA

Why it was recalled

Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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