Summaries of health policy coverage from major news organizations
Abbott Recalls Gonorrhea Test Kits That Could Give False Negatives
Abbott Laboratories is recalling 1.5 million gonorrhea test kits sold to hospitals and laboratories worldwide after it discovered that some of the tests produced false negative results, the AP/Contra Costa Times reports. The company said that it distributed the tests between Jan. 11 and June 24 and that 80% of the tests were sold to U.S. providers. Of the 32 recalled test kit lots, 16 contained tests that could give false negatives, Abbott found. Each test kit lot contains about 47,000 tests. The FDA on Friday said the recall is being placed in its highest-risk category and recommended that people who have tested negative for gonorrhea since Jan. 11 contact their physicians to determine if an additional test is necessary (Wolfe, AP/Contra Costa Times, 8/31). Abbott told its customers to destroy the defective test kits and retest patients with new kits, which will be provided free of charge (FDA release, 8/30).
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