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U.S. Department of Health and Human Services

Class 2 Device Recall OBSERVA

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  Class 2 Device Recall OBSERVA see related information
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
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/
bioMerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Sandra Perreand
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
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

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.