Software version 4 — Class II medical device recall Z-1864-2017
Terminated recall by BD LIFE SCIENCES, reported 2017-04-26, distributed in CA, CO, FL, IL, MN, MO, MT, NE…. The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Ope
| Recall number | Z-1864-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD LIFE SCIENCES, Sparks Glencoe, MD, United States |
| Recall initiated | 2015-07-29 |
| Classified | 2017-04-19 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-04-19 |
| Distributed | CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TN, TX, WA, WI |
| Countries outside the US | CA, HK, TR, TW |
| Reason classes | software |
| Model numbers | 441916 |
Product
Software version 4.44A utilized on the BD MAX System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1864-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.