Z-1189-2007

BacT/ALERT FN Culture Bottles, Product Number 259793

Name: Z-1189-2007 BacT/ALERT FN Culture Bottles, Product Number 259793
Creator: bioMerieux, Inc.
Published: 2007-02-16
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2007-02-16 / Terminated / root cause: sterility

FDA source

bioMerieux, Inc. began a recall of BacT/ALERT FN Culture Bottles, Product Number 259793 on 2007-02-16. The reason FDA records is "Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1189-2007
Status: Terminated
Initiated: 2007-02-16
Posted: 2007-08-22
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT FN Culture Bottles, Product Number 259793
Product code: MBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.
Quantity in commerce: 2,403 cases (100 bottles per case)
Distribution: Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom
Product codes and lots: Product number 259743, Lot 1015145

Product code MBD

K992432Class IBact/alert FnOrganon Teknika Corp. / cleared 1999-09-24

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)