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FDA ISSUES RECALL NOTICE ABOUT SIEMENS RAPID GRAM NEGATIVE COMBO PANELS

FDA ISSUES RECALL NOTICE ABOUT SIEMENS RAPID GRAM NEGATIVE COMBO PANELS

The FDA recently warned healthcare professionals of a recall of Siemens Healthcare Rapid Gram Negative Combo Panels. These devices are used to measure how certain bacteria respond to various types of antibiotics. Siemens Healthcare has recalled combo panels distributed between December 2013 and September 2014. The reason for the recall is that using the devices may lead to incorrect test results reporting "certain bacteria as sensitive to [some] antibiotics when the bacteria are actually resistant." This in turn could lead to "ineffective patient treatment, and in rare instances may contribute to death."

Siemens Healthcare has sent Urgent Medical Device Recall letter with safety instructions to its customers, urging them to stop using the recalled devices. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty] products will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm425288.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm425249.htm

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