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After all the hype, Theranos found to be defective medical device

Blood tests are readily used diagnostic procedures that many health care providers in California utilize in order to better understand the symptoms from which patients suffer. Traditionally, many blood tests require drawing vials of blood with a needle, but a medical tech startup claimed that it was changing the game of blood tests. Although the FDA initially released glowing reports of the new tests, it recently redacted those comments, instead labeling the product as a defective medical device.

Theranos -- a widely popular health care tech startup -- created the new blood test that reportedly functioned with only a single drop of blood. Rather than having to insert a needle into a vein, the test was supposedly able to gain the same information with only a prick of the finger. Theranos was widely praised for the advancement in technology, but after the Food and Drug Administration conducted inspections of the company's products and offices in Aug. and Sept. 2015, that all changed.

After the nearly three week long inspection, the FDA issued a form 483. Form 483 from the FDA indicates that a company has been found in violation of the manufacturing guidelines set out by the federal government. In particular, it determined that the classification of the blood test as a Class I medical device was incorrect, and that it should actually be categorized as a Class II -- a riskier device. Also, while Theranos claimed that test could replace previous analyses that required entire vials of blood, the FDA discovered that the product's design prevents it from fully functioning at its intended use for patients' needs.

California is one of the handful of states that are already using Theranos' blood test for patients, which could have unsettling implications. Incorrect or inconclusive results from a blood test can lead to a wrong diagnosis or delay in treatment for patients who might not have much time to give. Whether a defective medical device is impaired through design or production, victims should not have to bear the brunt of the aftermath. The civil court system allows for just compensation to be sought and awarded to victims who successfully navigate product liability claims made against the manufacturer or distributor.

Source: CBS, "FDA identifies defect in Theranos device", Kate Gibson, Oct. 27, 2015

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