FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
- Recall number
- Z-0373-04
- Recalling firm
- Becton Dickinson & Co.
- Product
- Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
- Status
- Terminated
- Initiated
- 2003-12-15
- Posted
- 2004-07-20
- Terminated
- 2004-06-21
- Reason
- Diagnostic test kit may exhibit false positive results.
- Root cause
- Other
- Action
- The recalling firm notified consignees by fax, e-mail and letters 12/15/03. The letter advised of the false positive test results and requested end users to discontinue use and discard remaining packages for replacement. Consignees were requested to return response form.
- Quantity
- 600 kits
- Distribution
- Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
- Lot, serial or model codes
- lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
- 510(k) numbers
- K022133
- PMA numbers
- not on file
- Product code
- GQG
- Firm FEI
- 1119779
- Firm city
- Sparks
- 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
- 2026-10-14
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