Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate

Recalled September 16, 2015 · FDA recall Z-2739-2015 · Siemens Healthcare Diagnostics

Hazard

Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay. · FDA Class II

Units

466

Sold at

Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.

Description

Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

Product

ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc

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