Z-0456-05

BacT/ALERT(BTA) Classic instruments

Name: Z-0456-05 BacT/ALERT(BTA) Classic instruments
Creator: bioMerieux
Published: 2004-09-17
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2004-09-17 / Terminated

FDA source

bioMerieux began a recall of BacT/ALERT(BTA) Classic instruments on 2004-09-17. The reason FDA records is "Over heating of memory board". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0456-05
Status: Terminated
Initiated: 2004-09-17
Posted: 2005-02-01
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT(BTA) Classic instruments.
Product code: MDB System, Blood Culturing
Reason for recall: Over heating of memory board.
FDA root cause: Other
Action: Consignees were notified by letter on September 17, 2004.
Quantity in commerce: 1626 units
Distribution: Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.
Product codes and lots: All codes associated with the product.

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)