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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Home Access and Home Access Express HIV-1 Test System-Home Access Health Corporation

DATE RECALL INITIATED:

October 6, 2006

PRODUCT / LOT NUMBER:

Home Access HIV-1 Test System

Lot Number Expiration Date


042108   May 2007
042109   May 2007
042110   June 2007
042111   August 2007
042113   August 2007
052101   November 2007

 

Home Access Express HIV-1 Test System

Lot Number Expiration Date


042010   February 2007
042011   February 2007
042012   May 2007
042013   May 2007
042014   May 2007
042015   August 2007
042016   August 2007
042017   August 2007
052001   August 2007

 

MANUFACTURER:

Home Access Health Corporation (HAHC)
Hoffman Estates, Illinois

REASON:

HAHC has identified that an incorrect "Use By" date was assigned to certain lots of HIV-1 Test Systems manufactured between June 2004 and January 2005. This error specifically relates to the expiration date associated with the lancets included with each test kit. Therefore, the lancets may not be sterile as of the printed "Use By" date. These lots should have been labeled with a "Use By" date of October 2006. HAHC recommends that these lots be removed from distribution and they will not be able to provide results for any blood specimen collected after October 31, 2006.

Customers are asked to return affected lot numbers to Home Access Health Corporation.

 

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