FDA Device

MagNA Pure LC Instrument; Catalog number 2236931.

Hazard

A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.

What You Should Do

Remedy

An urgent product correction letter dated 6/26/03 was sent to each customer advising them not to use DNA protocols until the software update has been installed.

Products

MagNA Pure LC Instrument; Catalog number 2236931.
Brand
Roche Diagnostics Corp.
UPC
All systems using software version 3.0

Units Affected

17