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U.S. Department of Health and Human Services

Class 2 Device Recall BD Max (tm) GBS Assay

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 Class 2 Recall
BD Max (tm) GBS Assay
see related information
Date Posted March 22, 2013
Recall Status1 Terminated on July 22, 2013
Recall Number Z-0976-2013
Recall Event ID 64310
Premarket Notification
510(K) Number
K111860 
Product Classification Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test - Product Code NJR
Product BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.
Code Information Lot/Exp. date: 2235001 2014-08-22
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action BD Diagnostic Systems issued an Urgent Product Recall letter via UPS delivery on December 11, 2012. The letter identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue and discard any affected product. BD would send replacements for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or Email to RegulatoryComplianceFax@BD.com.. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, contact BD Technical Services Department at 1-800-638-8663. The BD site in Belgium was notified via email. For questions regarding this recall call 410-316-4054.
Quantity in Commerce 27 boxes/648 cartridges
Distribution Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
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 = NJR and Original Applicant = BECTON DICKINSON & CO.
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