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Terminated

VIDAS 3 software v. 1.1.4

FDA Recall Z-1200-2017 · Posted 2017-02-14

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeLFZ
Date Initiated2017-01-11
Date Terminated2017-08-28
Product Quantity1161 units

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.

Firm Action

Consignees were notified via letter on January 11th, 2017.

Root Cause

Software in the Use Environment

Distribution Pattern

U.S.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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