Reported Apr 26, 2017 · Terminated
Software version 4.44A utilized on the BD MAX System
Bd Life Sciences
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BD LIFE SCIENCES · 54 Loveton Cir · Sparks Glencoe, MD · 21152-9202
Is this the product you have?
- Software version 4.44A utilized on the BD MAX System
- Lot codes and dates
- Catalog number 441916
- Amount recalled
- There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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