PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: August 31, 2016 Initiated: July 5, 2016 #Z-2601-2016

Product Description

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

Reason for Recall

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

Details

Units Affected
76
Distribution
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Location
Norwood, MA

Frequently Asked Questions

What product 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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 76.
Why was this product recalled?
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Which agency issued this recall?
This recall was issued by the FDA Devices on August 31, 2016. Severity: Low. Recall number: Z-2601-2016.