Z-1200-2017Class II

VIDAS 3 software v. 1.1.4

Name: Z-1200-2017 VIDAS 3 software v. 1.1.4
Creator: BioMerieux SA
Published: 2017-01-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-01-11 / Terminated / root cause: software

FDA source

BioMerieux SA began a recall of VIDAS 3 software v. 1.1.4 on 2017-01-11. FDA classified it as Class II and gives the reason as "During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field". 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-1200-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-02-14
Terminated: 2017-08-28
Recalling firm: bioMerieux, Inc.
Product: VIDAS 3 software v. 1.1.4
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Consignees were notified via letter on January 11th, 2017.
Quantity in commerce: 1161 units
Distribution: U.S.
Product codes and lots: REF: #412590, Lot: Software version 1.1.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1200-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1200-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-14

Product code LFZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)