FDA Device

MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

Hazard

A hardware/software problem will result in low elution volumes and bias sample results for various protocols.

What You Should Do

Remedy

Consignees were notified via recall letter dated 8/6/04.

Products

MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Brand
Roche Diagnostics Corp.
UPC
All units using software version 3.03.

Units Affected

192