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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT Classic (Only) with BacT/VIEW Software

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  Class 2 Device Recall BacT/ALERT Classic (Only) with BacT/VIEW Software see related information
Date Initiated by Firm December 19, 2006
Date Posted May 18, 2007
Recall Status1 Terminated 3 on December 08, 2009
Recall Number Z-0814-2007
Recall Event ID 37136
Product Classification in vitro diagnostic database software. - Product Code MDB
Product BacT/VIEW¿ Software, all versions. in vitro diagnostic database software.
Code Information Product Numbers: Software Version C.30a -22105-68, Update Disk; 22105-69 Install Disk
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
BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.
FDA Determined
Cause 2
Other
Action A customer notification was sent on/about December 19, 2006. Customers will be sent a new BacT/VIEW software version C.30b QTR 1 2007.
Quantity in Commerce 1233 units
Distribution Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
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.
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