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U.S. Department of Health and Human Services

Class 2 Device Recall Mycobacteria Growth Indicator Tube

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  Class 2 Device Recall Mycobacteria Growth Indicator Tube see related information
Date Initiated by Firm September 09, 2013
Date Posted October 19, 2013
Recall Status1 Terminated 3 on October 29, 2013
Recall Number Z-0028-2014
Recall Event ID 66325
510(K)Number K974883  
Product Classification System, blood culturing - Product Code MDB
Product BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part

Product Usage:
The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
Code Information Lot Number/ Exp. Date  3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		 An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
FDA Determined
Cause 2		 Error in labeling
Action BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 187,000 tubes
Distribution USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MDB and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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