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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Customer Notification - Vironostika HIV-1 - bioMerieux

DATE NOTIFICATION INITIATED:

July 20, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Kit Part Number      Kit Lot Number      EnzAbody Lot Number      Kit Expiration Date
259606                  121566                  1008926                           1/10/2007
259606                  121567                  1008926                           1/10/2007
259606                  121568                  1008926                           1/10/2007
259605 & 259717    160342                  1011220                           8/3/2007
259605 & 259717    160339                  1011021                           7/18/2007

 

MANUFACTURER:

bioMerieux, Inc.
Durham, NC

REASON:

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. bioMerieux is asking all customers to verify the appearance of the EnzAbody reagent prior to using it in an assay, not only for the lots listed above, but also as a general practice for all lots. 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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448