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Ventana Recalls Detection Kits Due to Potential False Negatives

NEW YORK (360Dx) – Ventana Medical Systems has recalled multiple detection kits using its FLO-LOK III dispenser due to potential false-negative test results, the US Food and Drug Administration announced today.

The FDA has identified the recall as a Class I recall, the most serious type.

The detection kits contain reagents that are used during immunohistochemistry lab tests. Arizona-based Ventana is recalling the 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," the FDA said in a statement. A false-negative result could result in inappropriate treatment or delay in treatment. While the affected detection kits can lead to serious injuries or death, the FDA noted that no such problems have been reported.

On August 2, Ventana, which is part of Roche, alerted affected customers and asked them to discontinue use of the affected dispensers from clinical testing. In some instances, Ventana said that a retrospective review and retesting of clinical cases using the affected dispensers would be necessary.

In a statement, Roche said that the recall was changed to a Class I recall from a Class II recall by the FDA on Sept. 14, but that the decision is a "reclassification of existing actions and is not a new field action. There is no change to customer guidance outlined in earlier communications, and this decision does not impact currently produced and/or distributed products. [Roche Tissue Diagnostics] is working closely with the FDA to close this issue."