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FDA Medical Device Recalls (openFDA)

BioMerieux SA: VIDAS 3 software v. 1.1.4

Recall number
Z-1200-2017
Recalling firm
BioMerieux SA
Product
VIDAS 3 software v. 1.1.4
Status
Terminated
Initiated
2017-01-11
Posted
2017-02-14
Terminated
2017-08-28
Reason
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
Software in the Use Environment
Action
Consignees were notified via letter on January 11th, 2017.
Quantity
1161 units
Distribution
U.S.
Lot, serial or model codes
REF: #412590, Lot: Software version 1.1.4
510(k) numbers
not on file
PMA numbers
not on file
Product code
LFZ
Firm FEI
1000611339
Firm city
Marcy L'Etoile
Firm state
not on file
Firm country
France

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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