Z-1177-2014Class II

bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R)...

Name: Z-1177-2014 bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R)...
Creator: Biomerieux Inc
Published: 2014-02-10
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2014-02-10 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO on 2014-02-10. FDA classified it as Class II and gives the reason as "The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1177-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-10
Posted: 2014-03-12
Terminated: 2017-03-16
Recalling firm: bioMerieux, Inc.
Product: bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
Reason for recall: The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent a recall notification letter to all of their consignees on 2/10/2014.
Quantity in commerce: 471 instruments
Distribution: Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.
Product codes and lots: Serial number range: AS 180-00001 to AS 180-00476

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1177-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

Product code LIB

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