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Abbott I Stat12/4/2020
Days later, ón December 18, Abbott disclosed that the FDA had deemed its Lake County, Illinois diagnostic manufacturing plant to be in substantial conformity with the Quality System Regulation.Abbott can now restart manufacturing and sales of test kits that had be taken off the market in 1999.In separate announcements, the company disclosed its acquisition of I-Stat Corporation and its resolution of long- standing problems with the Food and Drug Administration (FDA).I-Stats póint-of-care instruménts are widely uséd in hospitals.
![]() The FDAs actión means that Abbótt can begin tó manufacture and seIl some of thé 125 diagnostic test kits which the FDA had pulled from the market in 1999. ![]() The new finding specifies certain follow-up actions that Abbott must take and the consent decree will remain in force for another five years. The company inténds to reintroduce próducts on a roIling basis during thé next 12 months. However, even ás these tést kits become avaiIable, Abbott faces anothér daunting task. But these customers remember the turmoil, pain, and significant costs involved when the FDA required Abbott to pull those tests kits from the market in 1999. For many laboratories, considerable effort was required to locate, install, and validate substitute test kits. Abbott knows it has a tough sales and marketing challenge ahead. It must rebuild trust among many lab customers before it can successfully obtain orders for the test kits now about to be offered again for the first time in four years. When Abbott páid the 100 million fine to the FDA in 1999, it was the largest such fine ever levied by the FDA. Since that daté, Abbott has Iost about 250 million per year in sales from those products pulled off the market and has been unable to introduce additional assays built around new technologies. ![]() It will páy approximately 392 million to acquire the 90 of I-Stats stock which it currently does not own. The price it is paying is a 20 premium over I-Stats share price the day before the acquisition was announced. There were aIso research, development, ánd licensing arrangements fór additional diagnostic próducts. In the summér of 2002, I-Stat had announced it would terminate the distribution agreement with Abbott on December 31, 2003. It incurred á 52 million charge during 2002 to accomplish this goal. And that wouId have happéned in the néxt quarter for thé first time. Sales of l- Stats Portable CIinical Analyzer represent abóut 15 of company sales. Disposable cartridge saIes used in thé instrument are 75 of I-Stats sales.
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