GONORRHEA TEST KITS RECALLED BY ABBOTT LABORATORIES

The Food and Drug Administration (FDA) today announced that Abbott Laboratories, Inc., has initiated a worldwide recall of 32 lots of laboratory kits used to diagnose gonorrhea. The kits have been shown to be unreliable because they may give false negative results. These test kits were distributed to hospitals and laboratories from Jan. 11 to June 24 2002.

Gonorrhea is a serious, highly contagious sexually transmitted disease that affects both men and women. Women primarily suffer severe consequences from infection that is not detected and treated. Untreated gonorrhea in women can cause pelvic inflammatory disease that can lead to sterility. In pregnant women, infection can potentially cause abortion, premature delivery, or infection in the baby. If undetected and untreated in men, it can cause an infection of the urethra that makes urination painful and difficult. In both sexes, infection can spread through the bloodstream and infect the joints, skin, bones, tendons and other parts of the body.

"FDA is alerting the public to this recall to help protect the public health," said FDA Deputy Commissioner Lester M. Crawford. "We want to make sure laboratories that have purchased these test kits, physicians who have ordered these tests, and people tested for gonorrhea since January receive this information so they can act upon it."

People who have had a negative gonorrhea test since Jan. 11 may wish to ask their physician if they should be re-tested for gonorrhea.

Abbott notified its customers (clinical laboratories) to discontinue use of all test kits and to destroy any remaining product. Abbott also advised the laboratories to contact the health care providers served by their facility and have them determine if their patients need to be re-tested. The physician should offer a re-test to the patients whose test results were negative and who were not already treated. Repeat testing should be performed on a fresh specimen and not on retained specimens. Abbott Labs will reimburse expenses associated with repeat testing.

Abbott voluntarily recalled 32 lots of its gonorrhea test kits after learning through routine internal testing that certain lots did not meet specifications and, as a result, could report positive test results as negative. Upon further testing, Abbott determined that only 16 of these 32 lots did not meet internal release criteria. Abbott is continuing to investigate the cause of the problem.

The 16 lots that failed to meet specification when tested by Abbott are: 84073M400; 84075M400; 84142M300; 84146M300; 85487M200; 87007M400; 87103M400; 87243M100; 87377M200; 87899M200; 87905M200; 88097M300; 88105M300; 88107M300; 88439M200; and 88439M201. Patients who received a negative test result with test kits from these lots may need to be re-tested. Approximately 750,000 tests are affected.

Consumers or laboratories with questions can contact Abbott Laboratories at 1-800-527-1869. Physicians with questions on this recall should contact Abbott Laboratories at 1-866-233-0471.

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