The Recall Desk
HighFDA (Devices)·Z-2225-2021·Announced 2021-08-18

MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly

BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.

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: FDA Class II software recall with potential for incorrect test results affecting clinical decisions, but no reported illnesses or injuries. Theoretical harm without documented incidents justifies the High severity level.

Plain-English summary

BioMerieux SA is recalling MYLA software, a tool used to manage microbiology testing workflows and transmit results. The recall affects MYLA versions V4.8.0, V4.8.1, V4.7.0, and V4.7.1 when used with BCI Connect (UDI 03573026619244 and 03573026610975).

A software anomaly has been identified that, under certain conditions, can cause unwanted alterations to test results when using the BCI Connect scripting feature. This could potentially result in incorrect test data being transmitted or displayed, affecting clinical decision-making.

Approximately 248 systems have been distributed nationwide, with additional distribution to military and government facilities. No illnesses or injuries have been reported in connection with this issue.

BioMerieux is notifying affected customers. Healthcare facilities using the affected MYLA versions should contact BioMerieux or the FDA for further guidance on remediation options and software updates.

The recalled product

Product
MYLA 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.
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory / Diagnostic Software
Hazard
  • software-anomaly
  • result-alteration
  • data-integrity

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 (2)

  • MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT
  • UDI 03573026619244 and 03573026610975.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category