Detection kits recalled for possibility of false negative results

MGN
By  | 

SILVER SPINGS, Md. (WMTV) -- Ventana Medical Systems recalls multiple detection kits using the FLO-LOK III Dispenser contain staining chemicals used during IHC lab tests.

The chemicals — reagents, are used for immunohistochemistry testing. The dispensers release the staining reagents that change color to indicate a disease state or health condition through the detection of biomarkers.

Biomarkers are used as an aid in the diagnosis and management of patient treatment for many health conditions, including cancer. The results can also indicate whether a patient is likely to benefit from certain drugs.

Ventana Medical Systems is recalling the detection kits due to leaking and sticking of reagent dispensers which could cause a test result to indicate the absence of a biomarker when, in fact, the person does express the biomarker — a false negative.

A false negative may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences.

There are no deaths or serious health problems that have been reported. No complaints of false negative results have been received by the company.

For more information, including a full list of affected products, visit the FDA's
website.