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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX System

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  Class 2 Device Recall BD MAX System see related information
Date Initiated by Firm July 29, 2015
Date Posted April 04, 2017
Recall Status1 Terminated 3 on April 19, 2017
Recall Number Z-1864-2017
Recall Event ID 76900
510(K)Number K111860  
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product Software version 4.44A utilized on the BD MAX System
Code Information Catalog number 441916
Recalling Firm/
Manufacturer		 BD LIFE SCIENCES
54 Loveton Cir
Sparks Glencoe MD 21152-9202
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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 VAMC Austin.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NSX and Original Applicant = BECTON DICKINSON & CO.
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