Device recall: MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (”Middleware”) based on Web 2.0 technology…

Class II FDA enforcement event 72643. Recall start date: 3 Nov 2015. Status in the FDA record: Terminated. Termination date: 4 Dec 2017.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

bioMerieux, Inc. started this device recall on 3 Nov 2015. The firm address in the FDA record is in Durham, NC. FDA put the recall in Class II. FDA event 72643 has 7 product records. The first FDA enforcement report date is 23 Dec 2015. The record gives the status Terminated, with the termination date 4 Dec 2017.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

bioMerieux, Inc., Durham, NC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 72643: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0425-2016	MYLA CLINIC PATCH 3.2.0 CD 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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0426-2016	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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0427-2016	MYLA CLINIC PATCH 3.3.0 CD 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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0428-2016	MYLA MASTER DVD V4.0 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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0429-2016	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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0430-2016	MYLA CLI V3.X TO V4.1 DL380 SERVER 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)).	626 systems in total	Class II	Terminated	23 Dec 2015
Z-0431-2016	MYLA CLI V3.X TO V4.1 ML350 SERVER 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)).	626 systems in total	Class II	Terminated	23 Dec 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 57

Other events of the firm

Other FDA enforcement events of bioMerieux, Inc.
Initiated	Product (first record)	Type	Class	Records
4 Jun 2026	VITEK 2 AST-N447 TEST KIT Product reference 424620	Device	Class II	1
5 Jan 2026	VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem	Device	Class II	1
26 Jun 2025	VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consis	Device	Class II	1
14 Mar 2024	VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) A	Device	Class I	1
6 Feb 2023	MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments f	Device	Class II	1
9 Nov 2022	API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300	Device	Class II	94
20 Jul 2022	NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.	Device	Class II	1
13 Jul 2022	VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8	Device	Class II	1
29 Mar 2022	VITEK 2 Systems and VITEK 2 with MYLA.	Device	Class II	1
9 Feb 2022	VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.	Device	Class II	1

bioMerieux, Inc.: all 57 events

Official channels

FDA enforcement report Z-0425-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72643. https://recallregister.com/fda/ii/72643/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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,…
What quantity of product is in FDA event 72643?: The event has 7 product records. The first record gives this quantity: 626 systems in total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.