Date Initiated by Firm |
August 08, 2007 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on March 24, 2009 |
Recall Number |
Z-1319-2008 |
Recall Event ID |
46759 |
Product Classification |
in vitro diagnostic - Product Code GTQ
|
Product |
DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic. |
Code Information |
Catalog number: 223181, Lot number: 6122656, Exp: 20090705. |
Recalling Firm/ Manufacturer |
BD Diagnostic Systems / Lee Laboratories 1475 Athens Hwy Grayson GA 30017-1538
|
For Additional Information Contact |
Steve J. Strouphauer 678-259-2585
|
Manufacturer Reason for Recall |
Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
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. |
Quantity in Commerce |
26 units |
Distribution |
Nationwide Distribution and Canada |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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