—#178383

Product

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K141133
Affected lot / code info: software versions 1.2 and higher

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2019-10-22
Terminated: 2024-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.