Software version 4.44A utilized on the BD MAX System recallZ-1864-2017 · Bd Life Sciences · initiated Jul 29, 2015
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Life Sciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1864-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 29, 2015
- Posted by the FDA
- Apr 4, 2017
- 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.
- Product code
- NSX
- FDA submissions
- K111860
- 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 description
Software version 4.44A utilized on the BD MAX System
Code information (models, lots, serial numbers)
Catalog number 441916
Other devices under the same FDA submission
2 devices cleared under K111860 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD PCR Cartridge 437519Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall140 reports
- BD MAX™ GBS 441772Becton, Dickinson And Company · Nucleic acid amplification assay system, group b streptococcus, direct specimen test38 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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