Bac T/ALERT 3D 60
This recall has been terminated (originally issued September 7, 2005).
- Company
- Biomerieux, Inc.
- Recall Initiated
- May 27, 2005
- Posted
- September 7, 2005
- Terminated
- September 21, 2006
- Recall Number
- Z-0614-05
- Quantity
- 337 units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
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
Lot / Code Info
All Models (Not available in the US)
Root Cause
Other
Action Taken
Consignees were notified by letter on May 27, 2005.
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