RegWardenFDA facility compliance records
Recall

Class II — BioMerieux SA

Recalling firmBIOMERIEUX SA
Registered facilityView this company's 16 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonDuring 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.
ProductVIDAS 3 software v. 1.1.4
Quantity1161 units
DistributionU.S.
Initiated2017-01-11
Classified2017-02-14
Terminated2017-08-28
Recall numberZ-1200-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — BioMerieux SA (Z-1200-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76281/

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