Recall of Home Access and Home Access Express HIV-1 Test System
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.
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.