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U.S. Department of Health and Human Services

Class 3 Device Recall BD GeneOhm Cdiff Assay

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  Class 3 Device Recall BD GeneOhm Cdiff Assay see related information
Date Initiated by Firm March 05, 2010
Date Posted August 05, 2010
Recall Status1 Terminated 3 on October 15, 2010
Recall Number Z-2174-2010
Recall Event ID 55813
510(K)Number K081920  
Product Classification Clostridium Difficile Toxin Reagents - Product Code LLH
Product BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5***

Intended for use as an aid in diagnosis of CDAD.
Code Information Lot/Exp date: 08T09101 2010-06-30 08T09101A 2010-06-30 08T09103 2010-07-02 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kimberly Cartier
410-316-4258
Manufacturer Reason
for Recall		 In vitro diagnostic test kits do not perform to specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm notified accounts by an Urgent Product Recall letter on 03/05/2020. The letter identified the affected product and explained the reason for recall. It also advised customers to discontinue use of the affected product and discard any remaining inventory and fax back an acknowledgement form. The letter stated that BD will provide replacements for any discarded product. Further assistance can be obtained by contacting BD Technical Service at 1-888-436-3646.
Quantity in Commerce 31 kits
Distribution Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = LLH and Original Applicant = BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
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