Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bac T/ALERT 3D Combination Module

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Bac T/ALERT 3D Combination Module 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-0613-05
Recall Event ID 32377
510(K)Number K903505  
Product Classification System, Blood Culturing - Product Code MDB
Product Bac T/ALERT¿ 3D Combination Module
Code Information All Models
Recalling Firm/
Manufacturer		 BIOMERIEUX, INC.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact John Cusack, Sr.
919-620-2803
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		 Other
Action Consignees were notified by letter on May 27, 2005.
Quantity in Commerce 2,001 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.
-
-