Date Initiated by Firm | March 28, 2006 |
Date Posted | June 22, 2006 |
Recall Status1 |
Terminated 3 on March 07, 2008 |
Recall Number | Z-1161-06 |
Recall Event ID |
35518 |
Product Classification |
data managemen system - Product Code MDB
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Product | OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D |
Code Information |
Software version R.02.00.17 |
Recalling Firm/ Manufacturer |
bioMerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
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For Additional Information Contact | Sandra Perreand 314-731-8594 |
Manufacturer Reason for Recall | Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's |
FDA Determined Cause 2 | Other |
Action | The recalling firm telephoned customers who ordered the MB bottles and use the OBSERVA software ver. 2.0 to inform them of the issues. Recall letters were issued to all customers via overnight mail on 5/22/06 informing them a field representative would be visiting to make a short-term correction to the system. The letter also informed the customer a permanent correction to the software was scheduled for release later in the year. |
Quantity in Commerce | 51 units |
Distribution | WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France. |
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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