| | Class 2 Device Recall BacT/ALERT Classic (Only) with BacT/VIEW Software |  |
| Date Initiated by Firm | December 19, 2006 |
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| Date Posted | May 18, 2007 |
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| Recall Status1 |
Terminated 3 on December 08, 2009 |
| Recall Number | Z-0814-2007 |
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| 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. |
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| 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 |
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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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 1233 units |
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| Distribution | Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands. |
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| Total Product Life Cycle | TPLC Device Report |
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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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