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Terminated

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

FDA Recall Z-0373-04 · Posted 2004-07-20

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeGQG
Date Initiated2003-12-15
Date Terminated2004-06-21
Product Quantity600 kits

Reason for Recall

Diagnostic test kit may exhibit false positive results.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022133BD DIRECTIGEN EZ RSV KITBecton, Dickinson & CO · 2002-12-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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