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# Ventana Class 1 Recall of Detection Kits
- URL: https://www.fdaweb.com/ventana-class-1-recall-of-detection-kits/
- Published: 2018-10-01T12:00:00.000Z
- Updated: 2026-09-15T00:35:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142484

Ventana Medical Systems has recalled (Class 1) multiple detection kits due to a potential for false negative results caused by reagent dispenser issues The detection kits use the company’s Flo-Lok III Dispenser and contain staining chemicals (reagents) used during immunohistochemistry lab tests. The dispensers release reagents that change color to indicate a disease state or health condition (biomarkers). The kits have been found to leak or stick “which could cause a test result to indicate the absence of a biomarker when, in fact, the person does express the biomarker (false negative),” a [recall notice ](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm622007.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20Multiple%20Detection%20Kits%20by%20Ventana%20Medical%20Systems&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=623cd9651a824061a19ee31ecb48f767&elq=08e1a127e077420ca7f55336a4caf3a3&elqaid=5310&elqat=1&elqCampaignId=4238)says.