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U.S. Department of Health and Human Services

Class 3 Device Recall BD MAX Instrument

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 Class 3 Recall
BD MAX Instrument
see related information
Date Posted July 03, 2013
Recall Status1 Terminated on August 19, 2013
Recall Number Z-1662-2013
Recall Event ID 65431
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 Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Code Information Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 71 instruments
Distribution Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
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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