FDA Medical Device Recalls (openFDA)
Digene Corp: Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
- Recall number
- Z-1039-04
- Recalling firm
- Digene Corp
- Product
- Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
- Status
- Terminated
- Initiated
- 2004-05-28
- Posted
- 2004-07-20
- Terminated
- 2004-11-23
- Reason
- In vitro diagnostic test kit may produce false negative clinical results.
- Root cause
- Other
- Action
- The recalling firm notified consignees by phone 5/28/04 and by faxed letter 6/2/04. The letter advised of possible false negative test results and that such results should be retested immediately with replacement kits provided by the firm. The notification further advised that positive results should be considered valid if the assay meets all verification and calibration criteria. Consignees were requested to return product and response form.
- Quantity
- 206 kits
- Distribution
- Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
- Lot, serial or model codes
- Lot number 6234, EXP 10/20/04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LSO
- 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