FDA Device

Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

Hazard

In Vitro diagnostic test kit may produce false positive patient results

What You Should Do

Remedy

The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.

Products

Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
Brand
Digene Corp
UPC
Lot 2447/ exp 2004-01 Lot 2476/ exp 2003-08-14 Lot 2569/ exp 2003-09-24 Lot 2570/ exp 2003-11 Lot 2577/ exp 2003-09-24 Lot 2646/ exp 2003-08

Units Affected

1858 kits/ 96 assays per kit