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BD ProbeTec ET recall

This article was originally published in The Gray Sheet

Executive Summary

Firm's voluntary corrective action for Chlamydia/gonorrhea urine processing kits is deemed Class I recall. BD initiated the field action Jan. 10, following user complaints of indeterminate results from urine specimens stored with a urine processing pouch at refrigerated temperatures. BD's investigation concluded that a single lot of raw material used to manufacture pouches distributed between February and August 2004 sparked the problem. BD also found that a failure to use the amplification control during testing increases the risk of false negative results. The company notified customers worldwide by telephone and mail and adopted additional quality inspection and testing to ensure proper functioning of all other products...



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