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 Grove, IL 60515 USA
- Company
- Vysis
- Recall Initiated
- February 19, 2004
- Posted
- July 20, 2004
- Terminated
- August 27, 2004
- Recall Number
- Z-0640-04
- Quantity
- 234 kits
- Firm Location
- Downers Grove, IL
Reason for Recall
Some of the control slides did not have adequate cells deposited upon their surface.
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.
Lot / Code Info
catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
Root Cause
Other
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.