Z-0613-05

Bac T/ALERT 3D Combination Module

Name: Z-0613-05 Bac T/ALERT 3D Combination Module
Creator: Biomerieux, Inc.
Published: 2005-05-27
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2005-05-27 / Terminated

FDA source

BIOMERIEUX, INC. began a recall of Bac T/ALERT 3D Combination Module on 2005-05-27. The reason FDA records is "A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0613-05
Status: Terminated
Initiated: 2005-05-27
Posted: 2005-09-07
Terminated: 2006-09-21
Recalling firm: bioMerieux, Inc.
Product: Bac T/ALERT 3D Combination Module
Product code: MDB System, Blood Culturing
Reason for recall: A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
FDA root cause: Other
Action: Consignees were notified by letter on May 27, 2005.
Quantity in commerce: 2,001 units
Distribution: Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK
Product codes and lots: All Models

Product code MDB

K903505Class IBact/alert (Tm)Organon Teknika Corp. / cleared 1991-03-12

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)