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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 Software MYLA Middleware (Type of Software)

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 Class 2 Device Recall VITEK 2 Software MYLA Middleware (Type of Software)see related information
Date Initiated by FirmJuly 13, 2022
Create DateAugust 26, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1640-2022
Recall Event ID 90605
Product Classification Software, transmission and storage, patient data - Product Code NSX
ProductVITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Code Information VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactbioMerieux Customer Service Center
800-682-2666
Manufacturer Reason
for Recall		There are 7 reported software anomalies that may affect use of the device.
FDA Determined
Cause 2		Software design
ActionRecall notification was issued on or around July 13, 2022. Subsidiaries/distributors are instructed to identify/notify any impacted customer(s) in their region(s) of responsibility. Each customer is requested to return an Acknowledgement Form indicating that they are in receipt of the letter and will comply with the required actions (as appropriate to their laboratory).
DistributionInternational distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
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.
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