FDA Recall
Terminated
MagNA Pure LC Instrument; Catalog number 2236931.
Recall: Z-1001-03
·
Initiated May 27, 2003
Recall
- Recall Number
- Z-1001-03
- Event Number
- 26366
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 27, 2003
- Posted
- July 15, 2003
- Terminated
- November 18, 2003
- Address
- 9115 Hague Road, Indianapolis, IN, 46250-0457
Description
MagNA Pure LC Instrument; Catalog number 2236931.
Reason
Potential for false negative patient results with software version 3.0
Action
An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
Distribution
California, Georgia, Illinois, Maine, Michigan, Mississippi, New York Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
Quantity
17