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U.S. Department of Health and Human Services

Class 2 Device Recall Bac T/ALERT 3D 60

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  Class 2 Device Recall Bac T/ALERT 3D 60 see related information
Date Initiated by Firm May 27, 2005
Date Posted September 07, 2005
Recall Status1 Terminated 3 on September 21, 2006
Recall Number Z-0614-05
Recall Event ID 32377
510(K)Number K903505  
Product Classification System, Blood Culturing - Product Code MDB
Product Bac T/ALERT¿ 3D 60
Code Information All Models (Not available in the US)
Recalling Firm/
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact John Cusack, Sr.
Manufacturer Reason
for Recall
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
FDA Determined
Cause 2
Action Consignees were notified by letter on May 27, 2005.
Quantity in Commerce 337 units
Distribution Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK
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 = ORGANON TEKNIKA CORP.