MagNA Pure LC Instrument; Catalog number 2236931.
FDA device recall Z-1001-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Potential for false negative patient results with software version 3.0
- Action taken
- An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 17
- Distribution
- California, Georgia, Illinois, Maine, Michigan, Mississippi, New York Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
- Date initiated
- 2003-05-27
- Date posted
- 2003-07-15
- Date terminated
- 2003-11-18
- Location
- Indianapolis, IN
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