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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 Recall
BD GeneOhm Cdiff Assay
see related information
Date Posted August 05, 2010
Recall Status1 Terminated on October 15, 2010
Recall Number Z-2174-2010
Recall Event ID 55813
Premarket Notification
510(K) Number
K081920 
Product Classification Reagents, Clostridium Difficile Toxin - 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, Maryland 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLH and Original Applicant = BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
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