Abbott Laboratories Recalling 1.5 Million Gonorrhea Tests WorldwideAug 30, 2002 | AP Abbott Laboratories is recalling 1.5 million gonorrhea tests sold worldwide because they might give false negative results, the U.S. government said.
The Food and Drug Administration recommended that people who have tested negative for gonorrhea from Jan. 11 to June 24 ask their doctor if another test is necessary.
The FDA gave Friday's recall its highest risk category because of the dangers associated with false negatives for gonorrhea, a sexually transmitted disease that can worsen if left untreated.
"First, the person may not be getting the appropriate treatment," said Larry Spears, acting deputy director the FDA's Office of Compliance. "Second, they (may be) continuing to spread the disease to others."
Abbott Laboratories, based in Abbott Park, Illinois, distributed the kits to hundreds of hospitals and laboratories, 80 percent of them in the United States, from Jan. 11 to June 24.
Company spokesman Don Braakman said Abbott voluntarily recalled the tests July 18 and that all customers had been contacted and offered a refund. The company has since produced new test kits now available for sale.
Braakman said only a small percentage of people with gonorrhea would be affected by the defective tests since only those with low levels of the disease could be misdiagnosed.
In men, gonorrhea causes a burning sensation when urinating and irregular discharge from the penis. Undetected, it can lead to sterility. Women initially often show no or only mild symptoms, which can be mistaken for bladder or vaginal infections. If untreated, women can develop pelvic inflammatory disease, which can lead to infertility or complications in pregnancy.
Of the 32 sets of test kits recalled, the company later found that 16 contained tests that could give false readings. Each set contains about 47,000 tests.
The recalled sets are: 84073M400, 84075M400, 84142M300, 84146M300, 85487M200,87007M400, 87103M400, 87243M100, 87377M200, 87899M200, 87905M200, 88097M300, 88105M300, 88107M300, 88439M200 and 88439M201.