Recalls / —

—#27570

Product

MagNA Pure LC Instrument; Catalog number 2236931.

Affected lot / code info

All units with software version 3.0.

Why it was recalled

Potential for false negative patient results with software version 3.0

Root cause (FDA determination)

Other

Action the firm took

An Urgent Product Correction letter dated 5/27/03 was sent to each customer.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

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

Timeline

Recall initiated

2003-05-27

Posted by FDA

2003-07-15

Terminated

2003-11-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.