FDA Device recall Z-1864-2017
Software version 4.44A utilized on the BD MAX System
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Software version 4.44A utilized on the BD MAX System by Bd Life Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1864-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-29 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bd Life Sciences |
| Distribution | CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI |
Product
Software version 4.44A utilized on the BD MAX System
Reason
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.
Identifiers
| code_info | Catalog number 441916 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2017%22
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