FDA-Device2017-04-26Class II

Software version 4.44A utilized on the BD MAX System

BD LIFE SCIENCES

Hazard

The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.

Sold states

Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.

Affected count

There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.

Manufactured in

54 Loveton Cir, N/A, Sparks Glencoe, MD, United States

Products

Software version 4.44A utilized on the BD MAX System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1864-2017

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