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BD LIFE SCIENCES Recall: Software version 4.44A utilized on the BD MAX System

BD LIFE SCIENCES Recall: Software version 4.44A utilized on the BD MAX System is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: BD LIFE SCIENCES; Product: Software version 4.44A utilized on the BD MAX System; Reason for recall: The BD MAX System software version 4.44A contains a software

Recalling firmBD LIFE SCIENCES
ProductSoftware version 4.44A utilized on the BD MAX System
Reason for recallThe 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 instru
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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
Recall initiated20150729
Recall numberZ-1864-2017
Categorydevice
StateMD
CountryUnited States

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