FDAClass IIFebruary 22, 2017

VIDAS 3 software v. 1.1.4 recall: Software Issue

VIDAS 3 software v. 1.1.4

Why was VIDAS 3 software v. 1.1.4 recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF: #412590, Lot: Software version 1.1.4

Product
VIDAS 3 software v. 1.1.4
Recalling firm
BioMerieux SA
Quantity
1161 units
Distribution
U.S.
Recall date
February 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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