Z-0738-2013Class II

BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect...

Name: Z-0738-2013 BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect...
Creator: bioMerieux, Inc.
Published: 2012-12-25
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2012-12-25 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from... on 2012-12-25. FDA classified it as Class II and gives the reason as "BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0738-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-25
Posted: 2013-01-25
Terminated: 2014-06-03
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Product code: MDB System, Blood Culturing
Reason for recall: BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" and Acknowledgement Form on January 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local bioMerieux Customer Service Representative for additional assistance.
Quantity in commerce: 1690 cases
Distribution: Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
Product codes and lots: Catalog Number: 259789, Lots/Batch: 1031866

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0738-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-25

Product code MDB

K020931Class IBact/alert Sa Culture BottlebioMerieux, Inc. / cleared 2002-04-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)