—#30939

Product

Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.

FDA product code: GQG — Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K022133
Affected lot / code info: lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04

Why it was recalled

Diagnostic test kit may exhibit false positive results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.

Timeline

Recall initiated: 2003-12-15
Posted by FDA: 2004-07-20
Terminated: 2004-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30939. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.