BD LIFE SCIENCES: Medical Device Recall in 2017 - (Recall #: Z-1864-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Software version 4.44A utilized on the BD MAX System

Product Classification:

Class II

Date Initiated: July 29, 2015

Date Posted: April 26, 2017

Recall Number: Z-1864-2017

Event ID: 76900

Reason for Recall:

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.

Status: Terminated

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

Code Information:

Catalog number 441916

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated