Recall Z-1864-2017 ยท NSX
BD LIFE SCIENCES
Software version 4.44A utilized on the BD MAX System
| Date | Apr 4, 2017 (initiated Jul 29, 2015) |
| Status | Terminated |
| 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 instr |
| Root cause | Software design |
| Action | BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000. |
| Quantity | There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A. |
| Distribution | 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 V |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT Becton, Dickinson & CO, Feb 16, 2012 |