Important Customer Notification
DATE NOTIFICATION INITIATED:
July 20, 2006
PRODUCT / LOT NUMBER / EXPIRATION DATE:
|Kit Part Number||Kit Lot Number||EnzAbody Lot Number||Kit Expiration Date|
|259605 & 259717||160342||1011220||8/3/2007|
|259605 & 259717||160339||1011021||7/18/2007|
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.