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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 instrument using MYLA V4.8.0/4.8.1 and MYLA V4.7.1 software

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 Class 2 Device Recall VITEK 2 instrument using MYLA V4.8.0/4.8.1 and MYLA V4.7.1 softwaresee related information
Date Initiated by FirmJune 22, 2021
Create DateAugust 06, 2021
Recall Status1 Terminated 3 on February 06, 2023
Recall NumberZ-2225-2021
Recall Event ID 87985
Product Classification unknown device name - Product Code N/A
ProductMYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Code Information MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
FEI Number 1000611339
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information ContactbioMerieux Customer Service
800-682-2666
Manufacturer Reason
for Recall		Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
FDA Determined
Cause 2		Software design
ActionbioMerieux in North Carolina issued an 'URGENT PRODUCT CORRECTION NOTICE FSCA 5173-1 - MAY 2021" to their U.S. consignees on 6/22/2021 via email or overnight mail. The notice described the issue and listed the criteria that would result in the MYLA system being impacted. If all of the criteria are confirmed on the MYLA system, then the system will be impacted by this FSCA and the consignee is instructed to stop using the user scripting rules that change the value in field a4 (Final Category) and update the MYLA application to version 4.8.2.
Quantity in Commerce248 systems
DistributionDistribution in the U.S. was nationwide. There was also military and government distribution.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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