Z-0373-04

Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged...

Name: Z-0373-04 Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged...
Creator: Becton Dickinson & Co.
Published: 2003-12-15
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2003-12-15 / Terminated

FDA source

Becton Dickinson & Co. began a recall of Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030 on 2003-12-15. The reason FDA records is "Diagnostic test kit may exhibit false positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0373-04
Status: Terminated
Initiated: 2003-12-15
Posted: 2004-07-20
Terminated: 2004-06-21
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.
Product code: GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Reason for recall: Diagnostic test kit may exhibit false positive results.
FDA 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 in commerce: 600 kits
Distribution: Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
Product codes and lots: lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04

Product code GQG

K022133Class IBd Directigen Ez Rsv KitBecton, Dickinson & CO / cleared 2002-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)