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U.S. Department of Health and Human Services

Class 2 Device Recall Difco(tm) Shigella Antiserum Poly Group B

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 Class 2 Device Recall Difco(tm) Shigella Antiserum Poly Group Bsee related information
Date Initiated by FirmNovember 30, 2007
Date PostedAugust 16, 2008
Recall Status1 Terminated 3 on November 12, 2008
Recall NumberZ-1527-2008
Recall Event ID 46323
Product Classification Antisera, Shigella - Product Code GNB
ProductDifco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri Serotypes 1-6***Becton, Dickinson and Company Sparks, MD 21152*** Used for the identification of Shigella species by the slide agglutination test.
Code Information Lot 5059542 Exp March 30, 2008  Lot 6023471 Exp March 30, 2008 Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010 
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactBD Customer Service
800-675-0908
Manufacturer Reason
for Recall		In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.
Quantity in Commerce643 (recall total) vials
DistributionWorldwide Distribution
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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