MagNA Pure LC Instrument; Catalog number 2236931.
This recall has been terminated (originally issued July 15, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 27, 2003
- Posted
- July 15, 2003
- Terminated
- November 18, 2003
- Recall Number
- Z-1001-03
- Quantity
- 17
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for false negative patient results with software version 3.0
Distribution
California, Georgia, Illinois, Maine, Michigan, Mississippi, New York Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
Lot / Code Info
All units with software version 3.0.
Root Cause
Other
Action Taken
An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
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