Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MYLA software v. 4.7, 4.7.1, 4.8, 4.8.1, 4.8.2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MYLA software v. 4.7, 4.7.1, 4.8, 4.8.1, 4.8.2 see related information
Date Initiated by Firm September 02, 2021
Create Date October 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-0084-2022
Recall Event ID 88658
Product Classification Medical device data system - Product Code OUG
Product MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Code Information MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
Recalling Firm/
Manufacturer		 BioMerieux SA
3 route de Port Michaud
La Balme les Grottes France
For Additional Information Contact
+33 47495 7850
Manufacturer Reason
for Recall		 Under certain conditions, there is a risk for a false negative result.
FDA Determined
Cause 2		 Software design
Action A customer letter was issued to impacted subsidiaries and distributors on 09/08/2021. The letter includes instructions that the customer verify that they operate under the specific conditions required for the anomaly to occur: You are using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect AND You are managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA AND Your Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id) AND You are using the LIS capability to send Blood Culture requests containing the incubation expected duration (MTT) AND You are sending other requests than Blood Culture (Offline SU, ID,) on the same specimen than the one used for BC note: this condition is applicable only if it occurs after the previous ones, chronologically speaking - If the answer to ALL of the above questions is yes, then the customer must contact their bioMerieux representative for help to implement a workaround that should be used until MYLA version 4.9 is available. If the answer to any of the above question is no, the customer will not be impacted by this anomaly. The firm issued an updated Field Safety Corrective Action, FSCA #5308-2, on 9/29/2021 to subsidiaries and distributors which replaced FSCA #5308-1 to revise references in the FSCA document to only include the references of the impacted software. The firm added Annex I to the enclosed customer letter to be issued by the subsidiaries/distributors that provides guidance on how to check the MYLA software version and if BCI connectivity is being used.
Quantity in Commerce 542 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-