Z-0426-2016Class II

Myla Master Dvd 3.2 Cli Dl380

Name: Z-0426-2016 Myla Master Dvd 3.2 Cli Dl380
Creator: bioMerieux, Inc.
Published: 2015-11-03
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-11-03 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments... on 2015-11-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0426-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Posted: 2015-12-16
Terminated: 2017-12-04
Recalling firm: bioMerieux, Inc.
Product: MYLA MASTER DVD 3.2 CLI DL380 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)).
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.
Quantity in commerce: 626 systems in total
Distribution: 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.
Product codes and lots: REF # 415358, Serial number/Software version V3.2 CLI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0426-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0425-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0426-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0427-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0428-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0429-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0430-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0431-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)