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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT

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  Class 2 Device Recall BacT/ALERT see related information
Date Initiated by Firm August 14, 2006
Date Posted May 03, 2007
Recall Status1 Terminated 3 on December 08, 2009
Recall Number Z-0776-2007
Recall Event ID 36826
510(K)Number K981736  
Product Classification Blood Culturing System - Product Code MDB
Product BacT/ALERT 3D 60 Systems Software, Blood Culturing System
Code Information All Models
Recalling Firm/
Manufacturer
bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Brian Brundidge
919-620-2968
Manufacturer Reason
for Recall
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
FDA Determined
Cause 2
Other
Action Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.
Quantity in Commerce 10790 units, total for all models
Distribution Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
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.
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