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Gonorrhea test kits recalled; may yield false-negative results. (Retesting May be Necessary).
Those patients who have been tested for gonorrhea since Jan. 11 of this year may need to be retested.
At the end of August, the Food and Drug Administration announced that 32 lots of gonorrhea laboratory test kits distributed by Abbott Laboratories from Jan. 11 to June 24, 2002, had been voluntarily recalled by the company. These kits may give false-negative results and are considered unreliable, according to a statement issued by the FDA.
Abbott determined with routine internal testing that certain lots did not meet manufacturing specifications and could lead to false-negative results.
After conducting more tests, the company found that only 16 of the 32 lots did not meet manufacturing specifications. About 750,000 tests are affected by the recall.
"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," FDA deputy commissioner Lester Crawford, Ph.D., said in the statement.
Physicians should offer a ...
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Source: HighBeam Research, Gonorrhea test kits recalled; may yield false-negative results....