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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX (tm) (6 channel) Instruments

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 Class 2 Recall
BD MAX (tm) (6 channel) Instruments
see related information
Date Posted January 22, 2013
Recall Status1 Terminated on February 04, 2013
Recall Number Z-0701-2013
Recall Event ID 63949
Premarket Notification
510(K) Number
K111860 
Product Classification Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test - Product Code NJR
Product Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Code Information Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.
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
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
FDA Determined
Cause 2
DESIGN: Device Design
Action Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.
Quantity in Commerce 86 Instruments
Distribution USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
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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