Recall Z-0655-03 ยท MAQ Kit, Dna Detection, Human Papillomavirus
Digene Corp
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.
| Date | Mar 19, 2003 (initiated Feb 7, 2003) |
| Status | Terminated |
| Reason | In Vitro diagnostic test kit may produce false positive patient results |
| Root cause | Other |
| Action | 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. |
| Quantity | 848 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, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of di |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.