FDA Recall
Terminated
iVIEW DAB Detecion Kit. Catalog Number 760-091
Recall: Z-0928-03
·
Initiated May 7, 2003
Recall
- Recall Number
- Z-0928-03
- Event Number
- 26321
- Firm
- Ventana Medical Systems Inc
- FEI Number
- 1000125183
- Product Code
- KTO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 7, 2003
- Posted
- June 17, 2003
- Terminated
- May 3, 2004
- Address
- 1910 E Innovation Park Dr, Tucson, AZ, 85737
Description
iVIEW DAB Detecion Kit. Catalog Number 760-091
Reason
Kit does not stain tissues properly.
Action
Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
Distribution
Nationwide.
Quantity
409 kits