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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448