Z-0774-2007

BacT/ALERT 3D System Software, Blood Culturing System

Name: Z-0774-2007 BacT/ALERT 3D System Software, Blood Culturing System
Creator: bioMerieux, Inc.
Published: 2006-08-14
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2006-08-14 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of BacT/ALERT 3D System Software, Blood Culturing System on 2006-08-14. The reason FDA records is "Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems". 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-0774-2007
Status: Terminated
Initiated: 2006-08-14
Posted: 2007-05-03
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT 3D System Software, Blood Culturing System
Product code: MDB System, Blood Culturing
Reason for recall: Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
Root cause tag: software
FDA root cause: Other
Action: Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.
Quantity in commerce: 10790 units, total for all models
Distribution: Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Product codes and lots: All Models

Product code MDB

K934593Class IBact/alert 120Organon Teknika Corp. / cleared 1994-02-09

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)