Market Withdrawal of HIV-1 / HCV Assay-Procleix - Gen-Probe Inc

DATE WITHDRAWAL INITIATED:

 

January 18, 2005

 

PRODUCT / LOT NUMBERS:

HIV-1 / HCV Assay, Procleix

 

Lot Number: 401254

 

1000 Test Kit - Part Number 301031
5000 Test Kit - Part Number 301030

 

MANUFACTURER:

 

Gen-Probe Inc
San Diego, CA

DISTRIBUTOR:

Chiron Corp
Emeryville, CA

REASON:

Procleix HIV-1 / HCV Assay, Master Lot 401254, was found to contain an elevated level of copper. The source of the elevated copper was the raw material, Trehalose, which is also a component of the Enzyme Reagent. The increase in copper may affect kit performance.