A severe malfunction in cancer diagnosis devices: Roche, a large pharmaceutical equipment company, reported to the Health Ministry that a series of devices assisting in the laboratory diagnosis of cancerous tumors experienced a malfunction, meaning there was a rare risk of receiving false positive results and inappropriate treatments.
The malfunction implies that patients might have received a false positive result for a specific type of cancer—when the cancerous tumor is different, or it is not cancerous at all—and received incorrect treatment.
Extent of malfunction is unclear
The extent of the malfunction is still unclear, and the ministry does not yet know how many patients were affected as a result of the malfunction. However, the Health Ministry emphasized that this test is only part of the diagnostic process for certain tumorous diseases and that additional tests are used to diagnose cancer.
A statement from the Health Ministry read: “After consulting with professional authorities in the ministry and experts in the field of pathology, it appears that a certified and skilled pathologist can identify the incorrect diagnosis. However, the head of the medical division instructed hospitals to review cases where a positive result was received and to update the ministry if there were cases of incorrect diagnosis.”
