Z-0023-2013Class II

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the...

Name: Z-0023-2013 PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the...
Creator: Biomerieux Inc
Published: 2012-08-28
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2012-08-28 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux Inc began a recall of PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM)... on 2012-08-28. FDA classified it as Class II and gives the reason as "The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0023-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-10-09
Terminated: 2014-09-04
Recalling firm: bioMerieux, Inc.
Product: PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall: The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.
Quantity in commerce: 350 systems
Distribution: Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.
Product codes and lots: Serial numbers AS180-00001 to AS180-00376.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0023-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0023-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)