BacT/ALERT 3D 60 Systems Software, Blood Culturing System
This recall has been terminated (originally issued May 3, 2007).
- Company
- Biomerieux, Inc.
- Recall Initiated
- August 14, 2006
- Posted
- May 3, 2007
- Terminated
- December 8, 2009
- Recall Number
- Z-0776-2007
- Quantity
- 10790 units, total for all models
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All Models
Root Cause
Other
Action Taken
Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.