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Terminated

MagNA Pure LC Instrument; Catalog number 2236931.

FDA Recall Z-1001-03 · Posted 2003-07-15

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2003-05-27
Date Terminated2003-11-18
Product Quantity17

Reason for Recall

Potential for false negative patient results with software version 3.0

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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