Z-1864-2017Class II

Software version 4.44A utilized on the BD MAX System

Name: Z-1864-2017 Software version 4.44A utilized on the BD MAX System
Creator: Bd Life Sciences
Published: 2015-07-29
License: https://open.fda.gov/license/

BD Life Sciences / initiated 2015-07-29 / Terminated / root cause: software

FDA source

BD LIFE SCIENCES began a recall of Software version 4.44A utilized on the BD MAX System on 2015-07-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1864-2017
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Posted: 2017-04-04
Terminated: 2017-04-19
Recalling firm: BD Life Sciences
Product: Software version 4.44A utilized on the BD MAX System
Product code: NSX
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: Catalog number 441916

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1864-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1864-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

Product code NSX

K111860Class IBd Max Gbs Assay, Bd Max InstrumentBecton, Dickinson & CO / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)