ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Re
FDA device recall Z-0640-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Vysis
- Reason for recall
- Some of the control slides did not have adequate cells deposited upon their surface.
- Action taken
- Vysis telephoned their customers who received the two affected lots of slides beginning on 2/18/04, informing them of the complaints of missing cells on the control slides. The accounts were requested to check their stocks for any remaining slides from these two lots and return them to Vysis for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMW
- Quantity affected
- 234 kits
- Distribution
- DOmestically to accounts in Michigan, South Carolina, Illinois, Ohio, Connecticut, Arizona, New York, Texas, California, Oklahoma, Maryland, Virginia, Utah, Florida, Louisiana, Montana, Arkansas, Mass
- Date initiated
- 2004-02-19
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-27
- Location
- Downers Grove, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROVYSION BLADDER CANCER RECURRENCE KIT (K013785) | Vysis | 2002-02-08 |
| VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (K011031) | Vysis | 2001-08-03 |