Reported May 27, 2015 · Terminated

MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer…

bioMerieux, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402

Is this the product you have?

  • MYLA server HP ProliantDL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0
  • technology whichInterfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)
Lot codes and dates
  • Ref. #415603 and 411402
Amount recalled
730 units

Where it was sold

Why it was recalled

The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires service, provided remotely or on-site

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 13, 2017 · Data as of Sep 19, 6:54 PM UTC

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