bioMerieux, Inc. recalls MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which…

Recall date

November 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0429-2016

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / 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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)).