Recalls / —

—#34312

Product

MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

FDA product code

NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr

Device class

Class 2

Medical specialty

Hematology

Affected lot / code info

All units using software version 3.03.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

United States.

Timeline

Recall initiated

2004-08-06

Posted by FDA

2004-08-17

Terminated

2005-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34312. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.