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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
Products Sold
lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
Becton Dickinson & Co. is recalling Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, due to Diagnostic test kit may exhibit false positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Diagnostic test kit may exhibit false positive results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026