The Recall Desk
HighFDA (Devices)·Z-0084-2022·Announced 2021-10-20

MYLA Diagnostic System Software Versions Recalled for Risk of False Negatives

BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall addresses a risk for false negative results under certain conditions. The software failure could lead to missed diagnoses, representing significant potential for patient harm. However, no illnesses or injuries have been reported. This fits the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

BioMerieux SA is recalling MYLA diagnostic system software versions 4.7, 4.7.1, 4.8, 4.8.1, and 4.8.2, which are part of the VIRTUO diagnostic system. Approximately 542 units containing the affected software have been distributed.

Under certain conditions, the software may produce false negative results. This means the system could fail to detect a positive sample, potentially leading to missed diagnoses.

The affected software has been distributed worldwide, including throughout the United States and internationally to approximately 30 countries: Austria, Australia, Belgium, Canada, Switzerland, Chile, Colombia, 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, and South Africa.

Users of the affected VIRTUO system software should contact BioMerieux SA regarding this recall to obtain updated software versions and information about addressing this issue.

The recalled product

Product
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Manufacturer
BioMerieux SA
Category
Medical Device — Diagnostic System Software
Hazard
  • false-negative-result
  • diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • MYLA Software version 4.7
  • 4.7.1
  • 4.8
  • 4.8.1 and 4.8.2

Distribution

Distributed nationwide across the United States.

Related recalls

Same category