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Z-1864-2017 Class II Terminated

Recalled by BD LIFE SCIENCES — Sparks Glencoe, MD

FDA device recall Z-1864-2017 was initiated by BD LIFE SCIENCES on July 29, 2015 and is designated Class II. 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 u… The recall status is terminated (terminated April 19, 2017). Affected quantity: There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A..

Recall Details

Product Type: Devices
Report Date: April 26, 2017
Initiation Date: July 29, 2015
Termination Date: April 19, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.

Product Description

Software version 4.44A utilized on the BD MAX System

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.

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.

Code Information

Catalog number 441916