MagNA Pure LC Instrument; Catalog number 2236931.
This recall has been terminated (originally issued July 23, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 26, 2003
- Posted
- July 23, 2003
- Terminated
- November 19, 2003
- Recall Number
- Z-1044-03
- Quantity
- 17
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
Lot / Code Info
All systems using software version 3.0
Root Cause
Other
Action Taken
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.
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