Z-0750-2016Class II

BacT/ALERT FA, bioMrieux, Inc

Name: Z-0750-2016 BacT/ALERT FA, bioMrieux, Inc
Creator: bioMerieux, Inc.
Published: 2015-12-24
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-12-24 / Terminated / root cause: packaging

FDA source

bioMerieux, Inc. began a recall of BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for... on 2015-12-24. FDA classified it as Class II and gives the reason as "Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0750-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-24
Posted: 2016-02-04
Terminated: 2017-12-04
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Product code: MDB System, Blood Culturing
Reason for recall: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Biomerieux sent a Product Recall Notice letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the referenced part and lot number and discard remaining inventory according to their facility's procedure for culture media. Customers were also instructed to contact their local bioMrieux representative for product replacement.
Quantity in commerce: 2741 units in total
Distribution: Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
Product codes and lots: Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0750-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0749-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-03
Z-0750-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-03

Product code MDB

K020813Class IBact/alert Fa Culture BottlebioMerieux, Inc. / cleared 2002-04-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)