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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76900

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BD LIFE SCIENCES

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Software version 4.44A utilized on the BD MAX System

Z-1864-2017
Recall number
Z-1864-2017
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
BD LIFE SCIENCES
Quantity
There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 4.44A contains a software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog number 441916

Distribution pattern

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.