Z-0640-04

ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion...

Name: Z-0640-04 ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion...
Creator: Vysis
Published: 2004-02-19
License: https://open.fda.gov/license/

Vysis / initiated 2004-02-19 / Terminated

FDA source

Vysis began a recall of ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic... on 2004-02-19. The reason FDA records is "Some of the control slides did not have adequate cells deposited upon their surface". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0640-04
Status: Terminated
Initiated: 2004-02-19
Posted: 2004-07-20
Terminated: 2004-08-27
Recalling firm: Vysis
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
Product code: MMW System, Test, Tumor Marker, Monitoring, Bladder
Reason for recall: Some of the control slides did not have adequate cells deposited upon their surface.
FDA 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 in commerce: 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.
Product codes and lots: catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04

Product code MMW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)