—#27621

Product

MagNA Pure LC Instrument; Catalog number 2236931.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All systems using software version 3.0

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern: Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.

Timeline

Recall initiated: 2003-06-26
Posted by FDA: 2003-07-23
Terminated: 2003-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.