Z-1161-06

OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to...

Name: Z-1161-06 OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to...
Creator: bioMerieux Inc
Published: 2006-03-28
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2006-03-28 / Terminated / root cause: software

FDA source

bioMerieux Inc began a recall of OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D on 2006-03-28. The reason FDA records is "Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1161-06
Status: Terminated
Initiated: 2006-03-28
Posted: 2006-06-22
Terminated: 2008-03-07
Recalling firm: bioMerieux, Inc.
Product: OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
Product code: MDB System, Blood Culturing
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software version R.02.00.17

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)