Z-0928-2020Class II

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

Name: Z-0928-2020 BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Creator: Biomerieux Inc
Published: 2019-10-22
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2019-10-22 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation on 2019-10-22. FDA classified it as Class II and gives the reason as "Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu...". 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-0928-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-22
Posted: 2020-03-02
Terminated: 2024-08-06
Recalling firm: bioMerieux, Inc.
Product: BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their field action by an email to their subsidiaries on 10/22/2019. The subsidiaries then notified their customers by 2-day express via Fed Ex. In the US customer letter, customers are instructed to check their software version. If the VIDAS 3 software version is between 1.2.0 and 1.3.1, customers are instructed to check the archiving mode. If the archiving mode is Automatic When Results are Reported then customers are instructed how to configure the workaround, and to contact bioMerieux if the customer has the incorrect software configuration. bioMerieux then instructs impacted customers to review and interpret results in the context of the overall clinical procedure. Once this is completed to complete the acknowledgment form in Attachment A and return it the local bioMerieux representative and confirm receipt of this notice.
Quantity in commerce: 738 units
Distribution: US
Product codes and lots: software versions 1.2 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0928-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0928-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31

Product code JJE

K141133Class IVIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IIBiomerieux / cleared 2015-07-09

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)