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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5

DATE NOTIFICATION INITIATED:

June 8, 2010

PRODUCT / LOT NUMBER/EXPIRATION DATE:

COBAS AMPLICOR HIV MONITOR Test, v1.5

Lot Number: M02635

Catalog Number: 03155935018

Expiration Date:  June 30, 2010

MANUFACTURER:

Roche Diagnostics Corporation
Indianapolis, Indiana

REASON:

Roche Diagnostics has confirmed that the HIV-1 MONITOR Quantitation Standard (HIM QS) vials in the COBAS AMPLICOR HIV-1 MONITOR Test, v1.5 generate low or no absorbance signals. This results in invalid HIM QS results. Erroneous patient test results will not be generated due to an invalid HIM QS result. Customers are asked to discontinue the use of this lot and to contact Roche Molecular Diagnostics Technical Support.


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.