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 Grove, IL 60515 USA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Vysis
Lot Codes / Batch Numbers
catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
Products Sold
catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
Vysis is recalling ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis due to Some of the control slides did not have adequate cells deposited upon their surface.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the control slides did not have adequate cells deposited upon their surface.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CT, FL, IL, IN, LA, MD, MA, MI, MN, MO, MT, NY, NC, OH, OK, SC, TX, UT, VA
Page updated: Jan 10, 2026