FDA Medical Device Recalls (openFDA)
Digene Corp: Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
- Recall number
- Z-0654-03
- Recalling firm
- Digene Corp
- Product
- Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
- Status
- Terminated
- Initiated
- 2003-02-07
- Posted
- 2003-03-19
- Terminated
- 2003-07-16
- 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
- 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, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P890064S006"]
- Product code
- MAQ
- Firm FEI
- 3003572099
- Firm city
- Gaithersburg
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28