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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix PMIC108 Panels

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 Class 2 Recall
BD Phoenix PMIC108 Panels
see related information
Date Posted December 19, 2012
Recall Status1 Terminated on January 09, 2013
Recall Number Z-0570-2013
Recall Event ID 63737
Premarket Notification
510(K) Number
K070809 
Product Classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
Product BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Code Information Lot number 2053373
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 Ms. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 12,250 tests
Distribution Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
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 = LON and Original Applicant = BECTON, DICKINSON & CO.
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