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

FDA device recall Z-0654-03 · posted 2003-03-19 · Terminated

Recall details

Recalling firm

Digene Corp

Reason for recall

In Vitro diagnostic test kit may produce false positive patient results

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MAQ

Quantity affected

1858 kits/ 96 assays per kit

Distribution

Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, P

Date initiated

2003-02-07

Date posted

2003-03-19

Date terminated

2003-07-16

Location

Gaithersburg, MD