MagNA Pure LC Instrument; Catalog number 2236931.
FDA Recall Z-1044-03 · Posted 2003-07-23
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-06-26
Date Terminated2003-11-19
Product Quantity17
Reason for Recall
A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada 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.