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U.S. Department of Health and Human Services

Class 3 Device Recall DIFCO BACTO FA Streptococcus Group A

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 Class 3 Device Recall DIFCO BACTO FA Streptococcus Group Asee related information
Date Initiated by FirmAugust 08, 2007
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on March 24, 2009
Recall NumberZ-1319-2008
Recall Event ID 46759
Product Classification in vitro diagnostic - Product Code GTQ
ProductDIFCO 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.
FEI Number 1025402
Recalling Firm/
Manufacturer		 BD Diagnostic Systems / Lee Laboratories
1475 Athens Hwy
Grayson GA 30017-1538
For Additional Information ContactSteve 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
ActionBecton 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 Commerce26 units
DistributionNationwide Distribution and Canada
Total Product Life CycleTPLC Device Report
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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