AEGiS-FDA: Important notification regarding the Vironostika HIV-1 test kit

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

Important notification regarding the Vironostika HIV-1 test kit

Food and Drug Administration - July 26, 2006
Richard Klein

bioMerieux, Inc. has become aware of five HIV-1 finished kit lots in the field which have been reported to contain EnzAbody reagent that appears noticeably cloudy and/or flocculent, instead of clear and non-turbid as expected 30 minutes after reconstitution.

Kit lot numbers identified are 121566, 121567, 121568, 160342, and 160339 with EnzAbody Lot Numbers of 1008926, 1008926, 1008926, 1011220 and 1011021 respectively.

bioMerieux is asking all customers to verify the appearance of the EnzAbody reagent prior to using it in an assay as a general practice for all lots, whether or not they appear in this list.

If the EnzAbody reagent appears to be noticeably cloudy and/or flocculent 30 minutes after reconstitution, as a precaution, the reagent should not be used to perform the assay. Use of cloudy EnzAbody could possibly increase your risk of inaccurate HIV test results in patients and therefore should be avoided.

Richard Klein

Office of Special Health Issues

Food and Drug Administration
060726
FD060705

SOURCE: Food and Drug Administration (FDA).

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