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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002