Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055,…

Recall date

December 30, 2014

Source

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

Recall number

Z-1252-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary…

Why it was recalled

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.