Recall Z-0640-04 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
Vysis
ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers
| Date | Jul 20, 2004 (initiated Feb 19, 2004) |
| Status | Terminated |
| Reason | Some of the control slides did not have adequate cells deposited upon their surface. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Massachusetts, Minnesota, Missouri and North Carolina, and internationally to Germany and Japan. |
| FDA record | Open on fda.gov |