—#46301

Product

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

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Software version R.02.00.17

Why it was recalled

Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: bioMerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

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.

Timeline

Recall initiated: 2006-03-28
Posted by FDA: 2006-06-22
Terminated: 2008-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46301. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.