CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report

Myla Master Dvd V4.1 Cli recalled by bioMerieux

bioMerieux is recalling Myla Master Dvd V4.1 Cli, distributed nationwide in the US. The recall was initiated on 3 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF # 417191, Serial number/Software version V4.1 CLI

Quantity recalled626 systems in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0429-2016
FDA event ID: 72643
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2015
FDA classified: 16 Dec 2015
Reported: 23 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Nov 2015	Recall initiated by company
16 Dec 2015	Classified by FDA	+43 days
23 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

Where it was distributed

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.

Nationwide Alaska Alabama Arkansas Arizona California Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Is Myla Master Dvd V4.1 Cli recalled?

Yes. bioMerieux recalled Myla Master Dvd V4.1 Cli on 3 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0429-2016.

Why was it recalled?

MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Which lots are affected?

REF # 417191, Serial number/Software version V4.1 CLI

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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