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U.S. Department of Health and Human Services

Class 2 Device Recall Shigella Antiserum Poly Group B

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 Class 2 Device Recall 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-1528-2008
Recall Event ID 46323
Product Classification Antisera, shigella - Product Code GNB
ProductLee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test
Code Information Lot 6009070 Exp November 03, 2011
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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