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Terminated

DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.

FDA Recall Z-1319-2008 · Posted 2008-09-11

Recalling FirmBD Diagnostic Systems / Lee Laboratories
Recall StatusTerminated
Product CodeGTQ
Date Initiated2007-08-08
Date Terminated2009-03-24
Product Quantity26 units

Reason for Recall

Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.

Firm Action

Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution and Canada

Official Source

View FDA Recall →

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

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