Recall Z-1864-2017— BD LIFE SCIENCES

Name: FDA recall Z-1864-2017
Creator: U.S. Food and Drug Administration
Published: 2015-07-29

Class II · Terminated

Class II FDA medical device recall by BD LIFE SCIENCES, initiated 2015-07-29, terminated 2017-04-19. It names one FDA 510(k) clearance: K111860. Product: Software version 4.44A utilized on the BD MAX System. Reason: 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..

Recalling firm: BD LIFE SCIENCES
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Terminated: 2017-04-19
Firm location: Sparks Glencoe, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.