FDA Recall
Terminated
BacT/ALERT(BTA) Classic instruments.
Recall: Z-0456-05
·
Initiated September 17, 2004
Recall
- Recall Number
- Z-0456-05
- Event Number
- 30261
- Firm
- bioMerieux
- FEI Number
- 3002769706
- Product Code
- MDB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 17, 2004
- Posted
- February 1, 2005
- Terminated
- December 8, 2009
- Address
- 100 Rodolphe St, Bldg 1300, Durham, NC, 27712-9402
Description
BacT/ALERT(BTA) Classic instruments.
Reason
Over heating of memory board.
Action
Consignees were notified by letter on September 17, 2004.
Distribution
Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.
Quantity
1626 units