MagNA Pure LC Instrument; Catalog number 2236931.
FDA device recall Z-1044-03 · posted 2003-07-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 17
- Distribution
- Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
- Date initiated
- 2003-06-26
- Date posted
- 2003-07-23
- Date terminated
- 2003-11-19
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.