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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Medical Device Removal: COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor Test

DATE NOTIFICATION INITIATED:

October 27, 2009

PRODUCT / LOT NUMBER:

COBAS ® AmpliPrep/ COBAS ® AMPLICOR HIV-1 MONITOR Test

Catalog Number:  03309401018

Lot Number: M08154

MANUFACTURER:

Roche Diagnostics Corporation

Indianapolis, Indiana

REASON:

Roche Diagnostics has confirmed a problem with the HIV-1 MONITOR Quantitation Standard (QS) copy number encoded on the HIV-1 MONITOR Multi-Reagent (CS3) Cassette, packaged within the COBAS ® AmpliPrep/ COBAS ® AMPLICOR HIV-1 MONITOR Test, US IVD. The QS copy number was incorrectly designated as 107 copies/PCR instead of 97 copies/PCR. Customers are asked to discontinue the use of this lot and to request credit for affected products.


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.