Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog numbe

Recalled July 9, 2014 · FDA recall Z-1960-2014 · Siemens Healthcare Diagnostics

Hazard

ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU). · FDA Class II

Units

51 units

Sold at

Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican

Description

ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).

Product

ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →