Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D

FDA Recall Z-1161-06 · Posted 2006-06-22

Recalling FirmbioMerieux Inc
Recall StatusTerminated
Product CodeMDB
Date Initiated2006-03-28
Date Terminated2008-03-07
Product Quantity51 units

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

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑